[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"influenza\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:influenza":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,64,0,25,[9,47,60,86,113,138,166,190,222,257,281,312,347,370,395,421,448,468,488,519,542,568,590,609,632],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053229","phase-2-bpl-1357-against-h1n1-influenza-virus-challenge-100053229",false,"NCT07215858","BPL-1357 Against H1N1 Influenza Virus Challenge","Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study of the Safety and Efficacy of BPL-1357 Against H1N1 Influenza Virus Challenge","* INCLUSION CRITERIA:\n\nIndividuals must meet all of the following criteria to be eligible for study participation:\n\n1. Adults \\>=18 and \\\u003C= 55 years of age at the time of consent.\n2. Able to provide written informed consent.\n3. Non-smoker (i.e., tobacco and cannabis) and does not use vape or e-cigarette products currently. Also, must not have used any of these products extensively in the past (regular use more than 5 times per week, more than 6 months lifetime total).\n4. Has not received influenza vaccination of any type within 6 months prior to enrollment and consents to not receive influenza vaccination of any type until after the end of study participation (PBD63).\n5. Has not received any other vaccination of any type within 4 weeks prior to enrollment and consents to not receive any unlicensed vaccine until after the end of the study (PBD63).\n6. Has not received any broadly protective influenza vaccine in the past.\n7. Participants of childbearing potential must meet one of the following criteria through the end of study participation (PBD63):\n\n   1. Is infertile, including postmenopausal status (as defined by age .45 years plus no menses for \\>= 1 year without an alternative medical cause) or history of hysterectomy or bilateral oophorectomy.\n   2. Agrees that, when engaging in intercourse that can result in pregnancy, they will use an acceptable or highly effective form of contraception, and their male partner will use a condom with spermicide. Acceptable methods of female contraception include\n\n   the following:\n   * Bilateral tubal ligation\n   * Implant of levonorgestrel\n   * Injectable progestogen\n   * Oral contraceptive pills\n   * Diaphragm with spermicide\n   * Intrauterine device (IUD)\n   * Sexual abstinence\n   * Vasectomized partner\n8. Able to speak and understand English (NIH).\n9. Able to speak and understand English and\u002For Spanish (UTMB).\n10. A negative HIV test within 6 months before enrollment.\n11. Has not used IN medications (including but not limited to nasal sprays, sinus rinses), and has not routinely used over-the-counter medications (including but not limited to aspirin, decongestants, antihistamines, and other nonsteroidal anti-inflammatory drugs), and herbal medications (including but not limited to herbal tea or St. John's Wort) within 14 days (about 2 weeks) prior to study enrollment and agrees not to use these medications until after the end of study participation (PBD63), unless approved by the investigator.\n12. Agrees not to donate blood or blood products from enrollment through the final study visit (PBD63).\n13. Not planning on cohabitating with any high-risk individuals (e.g., infants, elderly, those with high-risk conditions (e.g., pregnancy, medical conditions such as those outlined in exclusion criterion 1) for at least 2 weeks after discharge from the inpatient portion of this study.\n14. Participant is willing and able to comply with all trial procedures.\n\nEXCLUSION CRITERIA\n\nIndividuals meeting any of the following criteria will be excluded from study participation:\n\n1. Current medical conditions (self-reported or medically documented) including but not limited to:\n\n   1. Chronic pulmonary disease (e.g., asthma, emphysema).\n   2. Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).\n   3. Chronic medical conditions requiring close medical follow-up or hospitalization (e.g., insulin-dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).\n   4. Immunosuppression, immune deficiency, or ongoing malignancy.\n   5. Neurological and neurodevelopmental condition (e.g., Bell s palsy, cerebral palsy, epilepsy, seizures).\n2. Body mass index (BMI) \\\u003C18 and \\>35.\n3. Pregnant or breastfeeding.\n4. History of postinfectious or postvaccine neurological sequelae including GBS.\n5. History of stroke within the past 5 years.\n6. Acute illness within 7 days prior to enrollment (PAD0).\n7. Known allergy to influenza vaccination or components contained in the influenza vaccine being used.\n8. Known allergy to influenza treatments (including oseltamivir or nonsteroidal anti-inflammatory medications).\n9. Known allergy to 2 or more classes of antibiotics (e.g., penicillins, cephalosporins, fluoroquinolones, or glycopeptides).\n10. Receipt of blood or blood products (including immunoglobulins) within 3 months prior to enrollment.\n11. Receipt of any unlicensed drug or investigational agent within 3 months or 5.5 half-life (whichever is greater) prior to enrollment.\n12. Receipt of any unlicensed vaccine within 6 months prior to enrollment.\n13. Self-reported or known history of alcoholism or drug abuse or use within 6 months prior to enrollment, or positive urine test for illicit drugs (i.e., amphetamines, cocaine metabolites, benzodiazepines, opiates, but not tetrahydrocannabinol) prior to vaccination on PAD0.\n14. Self-reported or known history of psychiatric or psychological issues that require treatment and are deemed by the PI to be a contraindication to protocol participation.\n15. History of angioedema or anaphylaxis.\n16. Study site staff who directly report to the study or site PI are excluded from participation.\n17. Any condition, event or lab value that, in the judgment of the investigator, is a contraindication to protocol participation or would place the participant at increased risk for participation.\n18. Any condition or event that, in the judgment of the investigator, impairs the participant's ability to give informed consent.\n\nIndividuals meeting any of the following criteria will be excluded from participation in Phase B:\n\n1. Positive urine test for illicit drugs (i.e., amphetamines, cocaine metabolites, benzodiazepines, opiates, but not tetrahydrocannabinol) prior to inoculation (PBD0).\n2. Acute illness within 7 days prior to inoculation with the human challenge virus (PBD0).\n3. Grade 3 or greater sign, symptom, or lab abnormality that is clinically significant and (in the opinion of the site PI) puts the participant at higher risk of adverse effects with influenza challenge.\n4. Pregnant or breastfeeding.\n5. Positive test for influenza within 8 weeks prior to challenge.",true,"ALL","18 Years","55 Years",{"count":22,"type":23},129,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","Background:\n\nInfluenza (flu) infections are a serious global health threat. Each year, between 3 and 5 million people get the flu, and up to 500,000 die from it. Current vaccines protect against seasonal flus, but broader vaccines are needed to protect against potential flu pandemics.\n\nObjective:\n\nTo test an experimental flu vaccine.\n\nEligibility:\n\nHealthy people aged 18 to 55 years.\n\nDesign:\n\nThe study will last 5 to 8 months and has 2 phases, A and B.\n\nThe study vaccine will be given either as a shot in the arm or as a nasal spray. Participants will receive 1 of 3 combinations: (1) study vaccine in the nose and placebo in the arm; (2) placebo in the nose and study vaccine in the arm; or (3) placebo in the nose and placebo in the arm. A placebo is just like the real vaccine but contains no active ingredients.\n\nPhase A: Participants will have 5 clinic visits over 56 days. They will receive a shot and a nasal spray at 2 of the visits, 28 days apart. At each visit, they will have a physical exam, with tests of their blood, urine, and nasal secretions. They will check their temperature at home and record any symptoms for 7 days after each vaccine.\n\nPhase B: Participants will stay in the hospital for at least 9 days. They will be infected with a flu virus. They will provide blood, urine, and nasal fluid samples. They will have tests of their heart function. They will remain in the hospital until they test negative for the flu 2 days in a row.\n\nThey will have 2 follow-up visits, 4 and 8 weeks after leaving the hospital.\n\n...",[29,30],"Influenza","Human",[29,32,33],"Vaccine","Human Challenge","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":23},"2026-07-16",{"date":42,"type":23},"2028-03-01",{"name":44,"class":45},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",2,{"id":48,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":49,"targetDuration":4,"studyType":24,"phases":50,"briefSummary":27,"conditions":51,"keywords":52,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":59,"locationsCount":46},"100609536",{"count":22,"type":23},[26],[29,30],[29,32,33],"2026-07-01",{"date":55,"type":38},"2026-07-02",{"date":57,"type":23},"2026-07-07",{"date":42,"type":23},{"name":44,"class":45},{"id":61,"slug":62,"hasResults":12,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":69,"phases":4,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":4,"leadSponsor":84,"locationsCount":85},"100162361","screening-for-lid-clinical-studies-unit-healthy-volunteer-protocols-100162361","NCT01386424","Screening for LID Clinical Studies Unit Healthy Volunteer Protocols","* INCLUSION CRITERIA:\n\n  1. Greater than or equal to 18 and less than or equal to 65 years old, and have no significant health abnormalities\n  2. Willing to consider taking part in a future LID Clinical Studies Unit healthy volunteer study\n  3. A female participant is eligible for this study if she is any of the following:\n* Of non-childbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are post-menopausal, as defined by no menses in greater than or equal to 1 year)\n* Of childbearing potential but agrees to practice effective contraception or abstinence (from heterosexual sex) for 4 weeks prior to enrolling into a spceific study and during the study.\n\nNOTE: Acceptable methods of contraception may include one or more of the following: 1) male partner who is sterile prior to the female participant's entry into the study and is the sole sexual partner for the female participant; 2) implants of levonorgestrel; 3) injectable progestogen;, 4) an intrauterine device with a documented failure rate of less than 1percent; 5) oral contraceptives; or 6) double barrier methods including diaphragm or condom with a spermicide.\n\n4\\. Willing to have samples stored for future research\n\nEXCLUSION CRITERIA:\n\n1. Self-reported history of any significant medical condition including but not limited to:\n\n   * Chronic pulmonary disease (such as asthma, emphysema)\n   * Chronic cardiovascular disease (cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects)\n   * Chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years (diabetes mellitus, renal dysfunction, hemoglobinopathies)\n   * Immunosuppression or cancer\n   * Neurological and neuro-developmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures)\n   * Drug and\u002For alcohol dependency and\u002For abuse\n2. Any condition that, in the judgment of the Principal Investigator, is a contraindication to protocol participation or impairs the volunteer s ability to give informed consent","65 Years",{"count":68,"type":23},5000,"OBSERVATIONAL","Background:\n\n* The Laboratory of Infectious Diseases (LID) Clinical Studies Unit (CSU) enrolls healthy volunteers into clinical studies to study infectious diseases.\n* Viruses can be highly infectious and contagious. They cause considerable illness in the United States each year and a good example of this is influenza (the flu). The LID CSU performs clinical studies to learn about these viral infections and assist in the development of vaccines and treatments for the infections. These clinical studies include influenza \"challenge studies\" as well as natural history studies and phase I trials involving vaccines for viruses carried by mosquitos such as Zika or Dengue virus.\n* In influenza challenge studies studies, doctors expose a person to a flu virus. Then they study the flu through the body's natural healing process. This information will help to find better ways to prevent the flu and may also improve treatments for the flu.\n* Natural history studies and phase I trials of new vaccines are performed so the researchers can learn how some viral infections occur and if new vaccines are safe and potentially effective in preventing the infections. In some of these studies, participants experience insect bites with special clean (non-infected) insects (such as mosquitos) to better understand the role of insects in these infections.\n\nObjectives:\n\n\\- To screen healthy volunteers for future CSU studies.\n\nEligibility:\n\n\\- Healthy people between the ages of 18 and 65\n\nDesign:\n\n* The 3- to 5-hour screening exam includes the following:\n* Medical history and physical exam\n* Standard blood tests including pregnancy, Hepatitis B and C, and HIV tests\n* Standard urine drug testing\n* Electrocardiogram (ECG) to test heart rhythm and function\n* Chest x-ray\n* Eligible volunteers are enrolled in the study for up to 1 year, until they take part in a CSU study or are found to be ineligible to participate.\n* Volunteers may withdraw from the study pool at any time.",[72,29],"Zika",[74,29,75,76,32,77,78],"Future","Flu","Observation","Healthy Volunteer","HV","2026-06-27",{"date":81,"type":38},"2026-06-30",{"date":83,"type":38},"2011-07-20",{"name":44,"class":45},1,{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":66,"enrollmentInfo":92,"targetDuration":4,"studyType":69,"phases":4,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":85},"100421774","observational-digital-biomarker-discovery-in-respiratory-virus-challenge-studies-100421774","NCT04772170","Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Able to provide informed consent.\n2. Current, recent, or planned enrollment in a respiratory virus challenge study at the NIH Clinical Center.\n3. Willing to wear devices as instructed.\n4. Willing to participate in monitoring activities as instructed.\n5. Willing to have monitoring data stored.\n6. Willing to have monitoring data shared with protocol investigators at NIH, University of Washington, and University of Toronto.\n7. Willing to have select clinical data from the challenge study such as vital signs, viral shedding, pulmonary function test and\u002For spirometry results, and clinical symptoms data shared with investigators at University of Washington and University of Toronto.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1\\. Any condition that, in the opinion of the investigator, contraindicates participation in this study.\n\nCo-enrollment guidelines: Participants must be co-enrolled, planned for co-enrollment, or recently enrolled in a challenge study. Co-enrollment in other studies is restricted but may take place after study staff notification and only with approval of the principal investigator or designee.",{"count":93,"type":23},1000,"Background:\n\nRespiratory viruses circulate throughout the year and around the globe. Wearable and sensor devices, like smartwatches, may be able to help monitor infectious diseases. Researchers want to use them to learn how respiratory viruses affect people in different ways.\n\nObjective:\n\nTo use digital devices to collect data from participants in challenge studies that could indicate subtle changes in health during an infection that might otherwise go unnoticed.\n\nEligibility:\n\nHealthy adults who have enrolled, were recently enrolled, or are scheduled to enroll in a challenge study.\n\nDesign:\n\nParticipants will stay at NIH for the duration of the challenge study (at least 9 days) and then will have outpatient follow-up visits (2-4).\n\nWhile at NIH, participants will wear a smartwatch at all times. It will record data like temperature, heart rate, breathing rate, and movements.\n\nParticipants will have a smartphone that records at all times to listen for coughing and changes in voice.\n\nParticipants will perform tasks every 4 hours during the daytime. They will record themselves coughing, breathing in deeply, and reading aloud. They will take videos of their face. They will play a game to test their reflexes and focus. They will measure their head temperature with their smartwatch.\n\nFor outpatient visits, participants will use one smartphone and the smartwatch to complete the above tasks.\n\nParticipants will be sent a smartwatch to wear at home at night to collect additional healthy data.\n\nParticipation will last the duration of each challenge study, and may range from 10 weeks to 2 years.",[29,96,97],"Respiratory Virus","Coronavirus",[99,100,101,102,103,104],"Wearable Digital Device","Bed Sensor","Smartphone","Cough Count","Smartwatch","Natural History","2026-06-17",{"date":107,"type":38},"2026-06-18",{"date":109,"type":38},"2023-10-23",{"date":111,"type":23},"2027-06-02",{"name":44,"class":45},{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":24,"phases":123,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":85},"100642084","phase-1-safety-and-pharmacokinetics-of-ingavirin-forte-capsules-90-mg--20-mg-valenta-pharm-jsc-russia-compared-with-ingavirin-capsules-90-mg-under-fasting-and-fed-conditions-100642084","NCT07645534","Safety and Pharmacokinetics of Ingavirin Forte, Capsules, 90 mg + 20 mg (Valenta Pharm JSC, Russia) Compared With Ingavirin, Capsules, 90 mg, Under Fasting and Fed Conditions.","An Open-Label, Randomized, Crossover Clinical Study to Evaluate the Safety and Pharmacokinetics of the Active Ingredients of Ingavirin Forte, Capsules, 90 mg + 20 mg (Valenta Pharm JSC, Russia) Fixed-Dose Combination Compared With Single-Ingredient Drug Ingavirin, Capsules, 90 mg Under Fasting and Fed Conditions.","Inclusion Criteria:\n\n1. Voluntarily and personally signed Informed Consent Form (ICF) by a participant obtained prior to the conduct of any study-related procedure;\n2. Males and females aged 18 to 45 years (inclusive);\n3. Confirmed healthy status, defined as the absence of clinically significant abnormalities based on clinical evaluation, laboratory assessments, and diagnostic procedures as specified in the protocol;\n4. Blood pressure (BP) level: systolic blood pressure (SBP) from 100 to 130 mmHg (inclusive), diastolic blood pressure (DBP) from 70 to 85 mmHg (inclusive);\n5. Heart rate (HR) from 60 to 89 beats\u002Fmin (inclusive);\n6. Respiratory rate (RR) from 12 to 20 per minute (inclusive);\n7. Body temperature from 36.0°C to 36.9°C (inclusive);\n8. Body mass index (BMI) of 18.5 kg\u002Fm² ≤ BMI ≤ 30 kg\u002Fm², with body weight for men being ≥ 55 kg and for women ≥ 45 kg;\n9. Agreement to use adequate methods of contraception throughout the study and for 30 days after its completion; for women of childbearing potential - a negative urine β-hCG test result;\n10. Subjects must demonstrate appropriate behavior and coherent speech;\n11. Ability to comply with the daily routine and diet prescribed by the study protocol.\n\nNoninclusion Criteria:\n\n1. Clinically significant allergic history;\n2. History of hypersensitivity to imidazolylethanamide of pentanedioic acid and N,N'-bis-\\[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl\\] diamide of malonic acid (XC9) and\u002For to the excipients contained in the investigational medicinal product;\n3. History of drug intolerance to imidazolylethanamide of pentanedioic acid and N,N'-bis-\\[2-(1,3-diazocyclopenta-2,4-dien-4-yl)ethyl\\] diamide of malonic acid (XC9) and\u002For to the excipients contained in the investigational medicinal product;\n4. Known galactose intolerance, lactase deficiency, or glucose-galactose malabsorption;\n5. Chronic diseases of the kidneys, liver, gastrointestinal (GI) tract, cardiovascular, lymphatic, respiratory, nervous, endocrine, musculoskeletal, genitourinary, or immune systems, or of the skin, hematopoietic organs, or eyes;\n6. History of gastrointestinal (GI) surgical procedures, with the exception of appendectomy performed at least 1 year prior to screening;\n7. Diseases\u002Fconditions that, in the investigator's opinion, may affect the absorption, distribution, metabolism, or excretion of the investigational medicinal product (IMP);\n8. Acute infectious diseases less than 4 weeks prior to screening;\n9. Use of medicinal products (MPs) that have a pronounced effect on hemodynamics, MPs affecting liver function (barbiturates, omeprazole, cimetidine, etc.), MPs prolonging the QT interval (antipsychotics (haloperidol, quetiapine, olanzapine, risperidone, sulpiride), antidepressants (fluoxetine, sertraline), antiarrhythmics (amiodarone), antibiotics (clarithromycin, azithromycin, moxifloxacin, levofloxacin, ciprofloxacin), antifungals (fluconazole), diuretics (furosemide)) less than 2 months prior to screening;\n10. Regular use of MPs less than 2 weeks prior to screening and single use of MPs less than 7 days prior to screening (including over-the-counter MPs, vitamins, dietary supplements, herbal medicinal products);\n11. Donation of blood or plasma less than 3 months prior to screening;\n12. Use of hormonal contraceptives by womeninitiated less than 2 months prior to the screening visit.\n13. Use of depot injections of any MPs less than 3 months prior to the start of screening;\n14. Pregnancy or breastfeeding; positive urine pregnancy test result for women of childbearing potential;\n15. Women of childbearing potential with a history of unprotected sexual intercourse within 30 days prior to study drug administration with a non-sterilized partner;\n16. Participation in another clinical trial within 3 months prior to screening or concurrently with the current study.\n17. Consumption of more than 10 standard alcohol units per week during the month prior to study enrollment, (1 standard unit = 500 mL beer, 200 mL wine, or 50 mL of strong alcoholic beverages), or history of alcoholism, drug dependence, or substance abuse.\n18. Currently smoking more than 10 cigarettes per day, or a history of smoking the specified number of cigarettes within the 6 months preceding screening; refusal to abstain from smoking while staying at the study center;\n19. Consumption of alcohol, caffeine, and xanthine-containing products within 7 days prior to IMP administration;\n20. Consumption of citrus fruits, cranberries, rose hips and products containing them, or St. John's wort-containing preparations or products within 7 days prior to IMP administration;\n21. Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours prior to IMP administration;\n22. Positive blood test result for antibodies to human immunodeficiency virus (HIV) 1 and 2, antibodies to Treponema pallidum antigens, hepatitis B surface antigen (HBsAg), or antibodies to hepatitis C virus antigens at screening;\n23. Clinically significant abnormalities on the electrocardiogram (ECG) in the medical history and\u002For at screening, including: QTcF interval (corrected by Fredericia) ≥430 ms in men and ≥450 ms in women;\n24. History of risk factors for torsades de pointes, such as heart failure, hypokalemia, or family history of long QT syndrome;\n25. Electrolyte imbalances (based on Na+, K+, Cl- levels at screening);\n26. Positive urine test for narcotic substances and potent medicinal products at screening;\n27. Positive breath alcohol test at screening;\n28. Planned hospitalization during the study period for any reason other than hospitalization required by this protocol;\n29. Inability or incapacity to comply with the protocol requirements, perform protocol-specified procedures, or adhere to the diet and activity restrictions;\n30. Belonging to a vulnerable group of volunteers: students of higher and secondary medical, pharmaceutical, and dental educational institutions; subordinate clinical or laboratory staff; employees of pharmaceutical companies; military personnel and prisoners; residents of long-term care facilities; low-income and unemployed individuals; representatives of national minorities; homeless individuals; refugees; individuals under guardianship or trusteeship; persons incapable of providing informed consent; as well as law enforcement officers;\n31. Any other condition which, in the Investigator's judgment, would preclude the subject's enrollment in the study or could lead to premature withdrawal, including adherence to fasting practices or special diets (e.g., vegetarian, vegan, sodium-restricted) or lifestyle factors (e.g., night shift work, extreme physical exertion).\n\nExclusion criteria:\n\n1. Subject's decision to discontinue participation in the study;\n2. Subject non-compliance with protocol requirements, including but not limited to missed study procedures, unauthorized use of prohibited concomitant medications, or failure to adhere to protocol-defined dietary and lifestyle restrictions.\n3. Occurrence of any medical condition or safety concern during study participation that could compromise subject safety (e.g., hypersensitivity reactions, etc.);\n4. Subjects enrolled in the study despite not meeting eligibility criteria (inclusion\u002Fexclusion criteria violations).\n5. Prolongation of the QTcF interval on ECG recording (\\>500 ms or \\>60 ms compared to baseline measured on Days 1, 8, 15, and 22);\n6. Occurrence of a severe adverse event (AE) and\u002For serious adverse event (SAE) during study participation\n7. Missed collection of two or more consecutive blood samples for pharmacokinetic analysis or three or more samples within one pharmacokinetic study period;\n8. The volunteer is receiving or requires treatment that may affect the pharmacokinetic parameters of the study drug;\n9. Occurrence of vomiting\u002Fdiarrhea within 8 hours after administration of the study drug;\n10. Positive urine test for narcotic substances and potent medicinal products;\n11. Positive breath alcohol test;\n12. Positive urine β-hCG test result in women;\n13. Emergence of any other reason during study participation that, in the Investigator's judgment, precludes the subject's continued compliance with protocol requirements.","45 Years",{"count":122,"type":23},36,[124],"PHASE1","This study aims to evaluate the safety and pharmacokinetic profile of the active ingredients Ingavirin forte, capsules, 90 mg + 20 mg (Valenta Pharm JSC, Russia) relative to single-entity Drug Ingavirin, capsules, 90 mg following administration under fasting and fed conditions.",[29,127],"Acute Respiratory Viral Infections","2026-06-11",{"date":130,"type":38},"2026-06-12",{"date":132,"type":38},"2025-07-11",{"date":134,"type":23},"2027-12-31",{"name":136,"class":137},"Valenta Pharm JSC","INDUSTRY",{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":69,"phases":4,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":85},"100639061","virological-surveillance-of-acute-respiratory-infection-in-primary-health-care-in-metropolitan-france-100639061","NCT07599449","Virological Surveillance of Acute Respiratory Infection in Primary Health Care in Metropolitan France","RS-viro IRA","Inclusion Criteria:\n\n* be seen by a general practitioner or pediatrician participating in the Sentinelles surveillance program;\n* between week 40 (late September-early October) and week 15 (mid-April) of each year\n* have an acute respiratory infection (ARI) as defined below: Sudden onset of fever (or feeling of fever) and respiratory symptoms\n* have given oral consent to participate in this monitoring or, in the case of minors, oral consent given by the child's legal guardian(s) present at the consultation\n\nExclusion Criteria:\n\n* a person who is subject to a court-ordered protective measure;\n* a person who is under guardianship or conservatorship, unless accompanied by their legal guardian or unless the legal guardian objects to their participation;\n* a person who is not in a condition to receive information or give consent.",{"count":146,"type":23},25000,"Every year in the fall and winter, numerous respiratory viruses (such as influenza viruses, SARS-CoV-2 (COVID-19), RSV, rhinovirus, and metapneumovirus) circulate in mainland France, causing acute respiratory infections (ARIs). These viruses can cause epidemics of varying severity, requiring close monitoring to determine their circulation levels and adapt public health measures accordingly. In France, ARI surveillance relies on two networks: the Sentinelles network in primary care and the RENAL network in hospitals. The Sentinelles surveillance is conducted in collaboration with Santé publique France, the National Reference Center for Respiratory Infection Viruses (Institut Pasteur and Hospices Civils de Lyon), and the University of Corsica. As part of the virological surveillance of ARIs, Sentinelles physicians are asked to collect nasopharyngeal swabs or saliva samples from a sample of patients presenting with an ARI during their clinic visits. This surveillance makes it possible to identify respiratory viruses circulating in primary care (general practice and pediatrics), to describe confirmed cases for each of the circulating viruses, and to estimate the impact of each on general practice. This surveillance also allows for the evaluation of the effectiveness of vaccines against influenza and COVID-19.",[149,150,29,151,152,153,154],"Respiratory Tract Infections (RTI)","Influenza -Like Illness","COVID - 19","RSV Infections","Rhinovirus Infection","Metapneumovirus Infection","NOT_YET_RECRUITING","2026-06-03",{"date":158,"type":38},"2026-06-05",{"date":160,"type":23},"2026-05-15",{"date":162,"type":23},"2031-05-20",{"name":164,"class":165},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":24,"phases":175,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":4},"100639712","light-based-immunomodulation-for-guarding-against-human-respiratory-tract-infections-100639712","NCT07610967","Light-based Immunomodulation for Guarding Against Human Respiratory Tract Infections","LIGHT","Inclusion Criteria:\n\n* Active Duty and DoD Beneficiaries (i.e. former military, spouse, dependent child) aged 18 years and older who work in the Mike O'Callaghan Military Medical Center at Nellis Air Force Base.\n\nExclusion Criteria:\n\n* Unable to comfortably insert RD-X19 into the mouth and keep in place for 5 minutes\n* Plans for head, neck or mouth surgery during the study period\n* Plans for major dental procedures (ie implants, wisdom teeth extraction etc) during the study",{"count":174,"type":23},130,[176],"NA","The purpose of trial is to determine if daily usage of a photobiomodulation device will decrease the incidence of upper respiratory tract infections (URI) due to COVID, influenza or other viruses.The RD-X10 device is handheld, can be self-administered, and has been shown to be safe in invivo studies.",[179,29],"COVID-19 Respiratory Infection","2026-05-20",{"date":182,"type":38},"2026-05-28",{"date":184,"type":23},"2026-06",{"date":186,"type":23},"2028-06",{"name":188,"class":189},"David Moss","FED",{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":197,"enrollmentInfo":198,"targetDuration":4,"studyType":24,"phases":200,"briefSummary":201,"conditions":202,"keywords":203,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":85},"100605959","phase-1-first-in-human-study-of-vnt-101-safety-tolerability-and-pharmacokinetics-100605959","NCT07169318","First-in-Human Study of VNT-101: Safety, Tolerability, and Pharmacokinetics","A First-in-Human, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose, and Food-Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VNT-101 Administered Orally to Healthy Adult Participants","Inclusion Criteria:\n\n1. Provides written informed consent prior to the initiation of any trial procedures.\n2. Able to understand and agrees to comply with all planned trial procedures and be available for all study visits.\n3. Healthy, adult, male or female (of non-childbearing potential only\\*), 18-59 years of age, inclusive, at the screening visit.\n\n   \\* Female participants of non-childbearing potential must be either surgically sterile (i.e., hysterectomy, bilateral tubal ligation, bilateral tubal occlusion \\[hysteroscopic sterilization\\], salpingectomy, and\u002For bilateral oophorectomy at least 26 weeks before Screening) or post-menopausal, defined as spontaneous amenorrhea for at least a year, with follicle-stimulating hormone (FSH) in the post-menopausal range at Screening, based on the central laboratory ranges.\n4. Continuous non-smoker who has not used nicotine-, tobacco-, cannabis-, or cannabidiol-containing products\\*\\* prior to the first dosing based on participant self-reporting.\n\n   \\*\\*The period before first dose is at least 3 months for tobacco and associated products and at least 60 days for cannabis and associated products.\n5. Body mass index (BMI)\\>\u002F=18.0 and \\\u003C\u002F= 30.0 kg\u002Fm\\^2 at the screening visit.\n6. Medically healthy\\*\\*\\* with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and ECGs, as deemed by the Principal Investigator (PI) or designee,\n\n   \\*\\*\\*Including the following:\n   1. Supine diastolic blood pressure is \\>\u002F= 40 mmHg and \\\u003C\u002F= 90 mmHg at the screening visit.\n   2. Supine systolic blood pressure is \\>\u002F= 90 mmHg and \\\u003C\u002F= 140 mmHg at the screening visit.\n   3. Supine heart rate is \\>\u002F= 60 bpm and\\\u003C\u002F= 100 bpm at the screening visit.\n   4. QTcF interval is \\\u003C\u002F= 460 msec (males) and \\\u003C\u002F=470 msec (females) and has ECG findings considered normal or not clinically significant by the PI or designee at the screening visit.\n   5. Estimated creatinine clearance \\>\u002F= 80 mL\u002Fmin based on the Cockroft-Gault equation and creatinine \\\u003C1.50 mg\u002FdL at the screening visit.\n   6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is not greater than 1.1 times the upper limit of normal (ULN), as specified by the testing laboratory.\n   7. Other clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the PI or designee.\n7. Must agree to refrain from using tanning salons, saunas, sunbathing, or prolonged sun exposure during participation in the study through the follow-up visit.\n8. Male participants must agree not to donate sperm during the study and for 90 days following the last administration of Study Product.\n9. Male participants must agree to use a medically accepted contraceptive regimen\\*\\*\\*\\* during participation and for 30 days after last administration of the study product or be vasectomized.\n\n   * Acceptable methods of contraception include abstinence from intercourse with a female of childbearing potential or use of male condoms with spermicide or surgical sterilization (vasectomy) of participant at least 26 weeks before the Screening.\n\nExclusion Criteria:\n\n1. History or presence of clinically significant medical or psychiatric condition or disease, making the participant unsuitable for enrollment in the opinion of the PI or designee.\n2. History of severe allergic or anaphylactic reactions to any prescription or non-prescription drug or vaccine.\n3. Participants who took any prescription medications within 14 days of first dosing or within 5 half-lives of the drug, whichever is longer.\n4. Participants who took any over the counter (OTC) medication\u002Fvitamins\u002Fherbal supplements\\* in the last 7 days prior to first dosing.\n\n   \\*Exception for occasional use of OTC acetaminophen (paracetamol) 325 to 500 mg every 4 hours not to exceed 3000 mg\u002Fday.\n5. History or diagnosis of a cardiovascular disease condition, including myocardial infarction, angina, congenital heart disease, cardiomyopathy, hypertension, or hypercholesteremia\\*\\*.\n\n   \\*\\*Defined as: clinically significant hypercholesteremia with high low-density lipoprotein (LDL) cholesterol (\\>\u002F= 160 mg\u002FdL)\n6. Increased risk for peptic ulcer\\*\\*\\*\n\n   \\*\\*\\*Defined as: participants with a history of gastric or duodenal ulcer, chronic non-steroidal anti-inflammatory drug use in the past 3 months, current smokers, alcohol consumption of \\> 21 alcoholic units per week (where 1 unit = 284 mL of beer, 25 mL of 40% spirit or a 125 mL of wine) or chronic atrophic gastritis,\n7. Female participant with a positive pregnancy test at the screening visit or at baseline or who is lactating.\n8. Positive urine drug toxicology test (or cotinine or alcohol results) at the screening visit or check-in.\n9. Has been on a diet incompatible with the on-study diet\\*\\*\\*\\*, in the opinion of the PI or designee, within the 30 days prior to the first dosing,\n\n   \\*\\*\\*\\*including consumption of grapefruit\u002FSeville orange within 14 days prior to first dosing,\n10. For Cohorts S2, S3, and S5 only, is known to be intolerant of a high fat\u002Fhigh calorie diet.\n11. Participants who are unlikely to comply with the study protocol OR those who would not be suitable candidates for participation in the opinion of the investigator.\n12. Participants who donated blood or plasma recently\\*\\*\\*\\*\\*\n\n    \\*\\*\\*\\*\\*Recently defined as within 30 days prior to Day -1, or loss of whole blood of more than 500 mL within 30 days prior to Day-1, or receipt of a blood transfusion within 1 year of study enrollment.\n13. Participated in a clinical study involving administration of an investigational drug in the past 30 days (90 days for injectable biological agent) before screening.","59 Years",{"count":199,"type":23},78,[124],"A randomized, double-blind, placebo-controlled Phase 1 study conducted at a single center with approximately 78 healthy adults aged 18-59 years. Part 1 Single Ascending Dose (SAD) will enroll 48 participants into six cohorts (S1-S6) to receive single oral doses of VNT-101 (100-1500 mg) or placebo under fasting or fed (S5 only) conditions. Part 2 Multiple Ascending Dose (MAD) will enroll 30 participants into three cohorts (M1-M3) to receive multiple oral doses of VNT-101 (250-750 mg BID Days 1-5, QD Day 6) or placebo under fasting conditions. Dose escalation in both parts will proceed after Protocol Safety Review Team (PSRT) review. The primary objective for Part 1 is to evaluate the safety and tolerability of single ascending oral (SAD) doses of VNT-101 in healthy adult participants under either fasting or fed conditions. The primary objective for part 2 is to evaluate the safety and tolerability of multiple ascending oral (MAD) doses of VNT-101 in healthy adult participants.",[29],[204,205,206,29,207,208,209,210,211,212,213],"Double-Blind","First-in-Human","Food-Effect Study","Multiple Ascending Dose","Nucleoprotein","Placebo-Controlled","Randomized","Safety","Single Ascending Dose","vnt-101","2026-05-07",{"date":216,"type":38},"2026-05-11",{"date":218,"type":38},"2025-09-16",{"date":220,"type":23},"2026-11-01",{"name":44,"class":45},{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":17,"sex":229,"minAge":19,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":24,"phases":232,"briefSummary":233,"conditions":234,"keywords":240,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":253,"locationsCount":256},"100578742","enhancing-maternal-vaccine-knowledge-and-uptake-the-introduce-programme-trial-100578742","NCT06815250","Enhancing Maternal Vaccine Knowledge and Uptake: The InTroDuce-Programme Trial","Effectiveness of the Influenza and Tdap (Tetanus, Diphtheria, Acellular Pertussis) Vaccination Educational and Learning Module (InTroDuce-Programme) in Improving Knowledge and Future Uptake of Vaccination Among Pregnant Mothers in Primary Care Clinics: A Randomised Control Trial Secondary IDs","Inclusion Criteria:\n\n* Pregnant women aged 18 years and older\n* Before or equal to 32 weeks of gestation as we need to follow-up the patients again at 36 weeks of gestation before delivery occurs.\n* Able to understand and consent to participation in the study.\n\nExclusion Criteria:\n\n* Pregnant women with severe anaphylactic or allergic reactions to previous dose of influenza or Tdap vaccination.\n* Non-Malaysian","FEMALE",{"count":231,"type":23},351,[176],"The goal of this InTroDuce-Programme interventional trial aims to test whether a web-based educational program can improve pregnant women's knowledge about Influenza and Tdap vaccinations and increase their intention to get vaccinated in the future. The main questions it aims to answer are:\n\nDoes the InTroDuce-Programme increase knowledge and future intention of pregnant mothers to get vaccinated against Influenza and Tdap? How does demographic factors, attitudes and barriers affect vaccination decisions among pregnant mothers?\n\nResearchers will compare InTroDuce-Programme to standard care (routine antenatal care) to see if InTroDuce-Programme works to improve knowledge and future intention of pregnant mothers to be vaccinated against Influenza and Tdap. Participants will:\n\nReceive the web-based educational module (InTroDuce-Programme), which covers the importance, safety, and effectiveness of vaccinations, as well as addressing common concerns.\n\nBe followed up one month after the intervention. Answer questionnaires before and after the intervention to measure changes in vaccination knowledge and future intention to get vaccinated",[235,236,237,29,238,239],"Vaccination Uptake","Knowledge","Tetanus, Diphtheria and Acellular Pertussis Vaccination","Web Based Intervention","Vaccine Knowledge",[241,242,243,244,245,246],"Influenza vaccination","Tdap vaccination","Educational module","Pregnant mothers","Vaccine knowledge","Vaccine uptake","2026-04-27",{"date":249,"type":38},"2026-05-01",{"date":251,"type":38},"2026-01-13",{"date":184,"type":23},{"name":254,"class":255},"Universiti Putra Malaysia","OTHER",4,{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":18,"minAge":265,"maxAge":266,"enrollmentInfo":267,"targetDuration":4,"studyType":24,"phases":269,"briefSummary":271,"conditions":272,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":280},"100523309","phase-3-a-surveillance-study-of-susceptibility-to-baloxavir-marboxil-in-pediatric-participants-with-influenza-and-transmission-of-influenza-to-household-contacts-100523309","NCT06094010","A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts","A Phase IIIb Multicenter, Single-arm, Open-label Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Patients With Influenza and Transmission of Influenza to Household Contacts","Pebblestone","Inclusion Criteria (Part A):\n\n* Participants with symptoms suggestive of influenza based on investigator's judgement with diagnosis confirmed by a positive local influenza test within 24 hours before full study screening\n* Participants with a negative severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) test within 48 hours before full study screening\n* Time interval between onset of influenza symptoms and the start of pre-dose examinations at screening is 48 hours or less\n\nInclusion Criteria (Part B):\n\n\\[A\\] IP:\n\n* Eligible to take part in Part A\n* Lives in a household with a HHC willing to be recruited as full HHC\n\n\\[B\\] HHCs:\n\n\\- Each HHC living in the home of an IP at the time of IP treatment must be screened for partial or full-study HHC eligibility\n\n\\[C\\] Partial HHC:\n\n* Starts screening within 1 calendar day after IP treatment\n* Negative influenza and SARS-CoV-2 test at screening after IP's treatment with baloxavir marboxil\n* HHC lives in a household where 1 or more HHCs meet the full-study HHC requirements AND at least 1 full-study HHC has not received the influenza vaccine within 6 months prior to screening\n* HHC lives in a household where 1 or more HHCs meet the full-study HHC requirements, and at least 1 full-study HHC has not received the influenza vaccine within 6 months prior to screening.\n* HHC lives with other HHCs (if applicable) who fulfill all the \"partial HHC\" criteria\n\n\\[D\\] Full-study HHC:\n\n* Fulfills the \"partial HHC\" criteria\n* Agrees to participate in the full study\n* Will reside in the IP's house for at least 12 of the next 15 days and will be present for scheduled study visits\n* No influenza symptoms within 7 days prior to screening\n* Does not have a moderate or worse active infections or infections requiring systemic or otherwise internally administered or otherwise internally administered antibiotic\u002Fantiviral\u002Fantifungal therapy\n\nExclusion Criteria (Part A):\n\n* Participants with severe influenza virus infection requiring inpatient treatment\n* Severely immunocompromised participants (including participants receiving immunosuppressant therapy, or those with cancer or human immunodeficiency virus \\[HIV\\] infection) as defined by the investigator\n* Participants with concurrent (non-influenza) infections requiring systemic anti-microbial and\u002For anti-viral therapy at the pre-dose examinations\n* Treatment with baloxavir marboxil, peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir or amantadine within 30 days prior to screening\n* Treatment with an investigational influenza-specific monoclonal antibody within 6 months or 5 half-lives, whichever is longer, prior to screening\n* Treatment with an investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to screening\n* Known hypersensitivity to baloxavir marboxil or the drug product excipients\n* Females who have commenced menarche (i.e., child-bearing potential)\n\nExclusion Criteria (Part B):\n\n* IPs who fulfil an exclusion criterion for Part A\n* HHCs deemed to require influenza post-exposure prophylaxis with influenza antiviral treatment due to their risk of developing influenza-related complications in accordance with local guidelines or clinical practice\n* HHCs diagnosed with influenza by health care professional in the past 4 weeks","3 Weeks","11 Years",{"count":268,"type":23},1100,[270],"PHASE3","This study consists of two parts: Part A Surveillance and Part B Transmission.\n\nThe main purpose of Part A is to evaluate the prevalence of pre-dose and treatment-emergent amino acid substitutions in pediatric participants' \\\u003C12 years with influenza treated with baloxavir marboxil.\n\nPart B will include a subset of Part A participants who have household contacts (HHCs) recruited to the study. Part B will evaluate the incidence of onward influenza transmission from pediatric index participants (IPs) under 5 years of age and those aged 5 to under 12 years, treated with baloxavir marboxil, to their HHCs. Participants will no longer be enrolled to Part B Transmission as per protocol version 3.",[29],{"date":249,"type":38},{"date":275,"type":38},"2023-11-22",{"date":277,"type":23},"2027-06-30",{"name":279,"class":137},"Hoffmann-La Roche",51,{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":289,"enrollmentInfo":290,"targetDuration":4,"studyType":24,"phases":292,"briefSummary":294,"conditions":295,"keywords":297,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":85},"100580792","phase-4-woodsmoke-exposure-influenza-infection-and-nasal-immunity-100580792","NCT06841913","Woodsmoke Exposure, Influenza Infection, and Nasal Immunity","The Effects of Woodsmoke Exposure on Nasal Immune Responses to Influenza Infection in Normal Human Volunteers","SmokeyFlu","Inclusion Criteria:\n\n* Normal lung function,\n* oxygen saturation of \\>94%,\n* normal blood pressure,\n* no respiratory symptoms on history, no abnormalities on exam, normal pulmonary function testing,\n* 18-49 Years of age.\n\nExclusion Criteria:\n\n* A history of significant chronic illnesses (to include diabetes, autoimmune diseases, immunodeficiency state, known ischemic heart disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or asthma, hypertension)\n* Positive pregnancy test within 48 hours of the time of challenge\n* Use of any inhaled substance (for medical or recreational purposes).\n* Nonsmokers must have been abstinent from smoking for the prior 12 months, having not smoked more than 1 pack over the course of the previous year.\n* History of allergy to eggs\n* Acute, non-chronic, medical conditions, including (but not limited to) pneumonia or bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally resolved symptomatically for 3 weeks\n* Unspecified illnesses, which in the judgment of the investigator increase the risk associated with the experimental LAIV infection, will be a basis for exclusion.\n* Expected exposure of subject to immunocompromised individuals (who can be infected by LAIV) for the 3 weeks following LAIV inoculation.\n* Use of immunosuppressive drugs within the past 6 months.\n* Previous Woodsmoke exposure \\\u003C3 weeks, which is considered to an appropriate washout period","49 Years",{"count":291,"type":23},112,[293],"PHASE4","This study will investigate the effects of woodsmoke (WS) exposure on human nasal mucosal immune responses to viral infection. The study tests the hypotheses that WS exposure modifies biomarkers of nasal mucosal immune function, increases in Live Attenuated Influenza Virus (LAIV) -induced nasal symptoms, and reduces mucosal antibody production.",[296,29],"Smoke Exposure",[298,299,29,300,301,302],"LAIV","Flumist","Wood Smoke","Smoke","Fire","2026-04-24",{"date":305,"type":38},"2026-04-30",{"date":307,"type":38},"2025-09-26",{"date":309,"type":23},"2028-12-31",{"name":311,"class":255},"University of North Carolina, Chapel Hill",{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":18,"minAge":320,"maxAge":321,"enrollmentInfo":322,"targetDuration":4,"studyType":24,"phases":324,"briefSummary":325,"conditions":326,"keywords":329,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":346},"100512024","phase-2-high-vsstandard-dose-influenza-vaccine-in-pediatric-solid-organ-transplant-sot-recipients-100512024","NCT05947071","High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients","Comparison of High vs Standard Dose Influenza Vaccines in Pediatric Solid Organ Transplant Recipients","PSOT","Inclusion Criteria:\n\n1. Male or female, 3-17 years of age at time of enrollment\n2. Pediatric kidney, heart, and\u002For liver transplant recipient ≥1 month and \\\u003C24 months post-transplant at the time of study immunization\n\n   * Note: Inclusion of recipients of multiple organs is permitted but is limited to recipients of any combination of organs including kidney, heart and\u002For liver\n   * Note: Participants undergoing re-transplantation are permitted\n3. Anticipated to be available for duration of the study\n4. Available by telephone, email, or text message\n\nExclusion Criteria:\n\n1. Inability (i.e. not able to understand and provide consent) or unwillingness of a participant\u002Fparent\u002Flegal guardian to give written informed consent or comply with study protocol\n2. History of severe hypersensitivity to influenza vaccination or anaphylaxis to eggs\u002Fegg protein\n3. History of severe latex hypersensitivity\n4. History of Guillain-Barre syndrome\n5. History of lung or intestine transplant\n6. HIV positive patients (testing within 24 months of enrollment)\n7. Receipt of current season's influenza vaccine post-transplant prior to enrollment in the study\n8. Currently pregnant or lactating (females of childbearing age may be enrolled based on self-report, urine pregnancy test must be performed prior to each influenza vaccine)\n9. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.","3 Years","17 Years",{"count":323,"type":23},312,[26],"Influenza virus is a significant pathogen in pediatric solid organ transplant (SOT) recipients. However, these individuals respond poorly to standard-dose (SD) inactivated influenza vaccine (IIV). Recent studies have investigated two strategies to overcome poor immune responses in SOT recipients: (1) administration of high-dose (HD)-IIV compared to SD-IIV and (2) two doses of SD-IIV compared to one dose of SD-IIV in the same influenza season. One study compared HD-IIV vs. SD-IIV in adult SOT recipients and noted that HD-IIV was safe and more immunogenic; however, the median post-transplant period was 38 months. A phase I pediatric study comparing a single dose of HD-IIV vs. SD-IIV was safe with higher immunogenicity, but the study was limited by small sample size and median post-transplant vaccine administration was 26 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV one month apart compared to one-dose of SD-IIV revealed modestly increased immunogenicity when given at a median of 18 months post-transplant. Therefore, these studies lack both evaluation in the early post-transplant period and substantive pediatric populations. Additionally, the administration of two-doses of HD-IIV in the same influenza season has not been evaluated in pediatric SOT recipients. Thus, the optimal immunization strategy for pediatric SOT recipients less than 24 months post-transplant is unknown. In addition, immunologic predictors and correlates of influenza vaccine immunogenicity in pediatric SOT recipients have not been well-defined.\n\nThe central hypothesis of our proposal is that pediatric SOT recipients 1-23 months post-transplant who receive two doses of HD-quadrivalent inactivated influenza vaccine (QIV) will have similar safety but higher Hemagglutination Inhibition (HAI) geometric mean titers (GMTs) to influenza antigens compared to pediatric SOT recipients receiving two doses of SD-QIV.",[327,328,29],"Immunization; Infection","Transplantation Infection",[29,330,331,332,333,334,335,336,337],"Vaccination","Immunization","High Dose","Fluzone","Standard Dose","Influenza, Human","Communicable Diseases","Pediatric transplantation","2026-04-16",{"date":340,"type":38},"2026-04-21",{"date":342,"type":38},"2024-09-26",{"date":344,"type":23},"2027-09-01",{"name":44,"class":45},8,{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":355,"targetDuration":4,"studyType":24,"phases":356,"briefSummary":357,"conditions":358,"keywords":359,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":85},"100563747","generating-mucosal-immunity-after-influenza-infection-and-vaccination-in-lung-and-lymphoid-tissue-100563747","NCT06620185","GEneRating Mucosal Immunity After INfluenzA Infection and Vaccination in Lung and Lymphoid TissuE","A Two-arm, Non-randomised, Open-label Experimental Medicine Study to Compare Immune Responses Between Healthy Volunteers Aged 18-55years Receiving Either an Intranasal Live-attenuated Influenza Vaccine or Viral Challenge With GMP Influenza A\u002FBelgium\u002F4217\u002F2015 (H3N2)","GERMINATE","Inclusion Criteria:\n\n* Adults aged between 18-55 years inclusive\n* Sero-suitable as defined by a serum micro-neutralisation titre \\\u003C1:20\n* Female participant who is not of child-bearing potential as assessed by an investigator OR is willing and able to use contraception as described in the protocol\n* Male participants who are willing to use one of the contraception methods described in the protocol\n* In good health with no clinically significant medical conditions\n\nExclusion Criteria\n\n* History of clinically significant\u002Fcurrently active conditions;\n\n  * Cardiovascular, thromboembolic\u002Fcerebrovascular disease.\n  * Types of chronic respiratory disease in adulthood.\n  * Significant wheeze in the past\n  * Respiratory symptoms including wheeze, resulting in hospitalisation\n  * Known bronchial hyperactivity to viruses\n  * Diabetes mellitus\n  * Migraine with associated symptoms like hemiplegia\u002Fvision loss. Cluster headache\u002Fmigraine\u002Fprophylactic treatment for migraine.\n  * History of autoimmune disease\u002Fknown immunodeficiency of any cause\n  * Immunosuppression.\n  * Known coagulation disorder\u002Fanticoagulant therapy\n  * Psychiatric illness including participants with a history of depression and\u002For anxiety with associated psychiatric comorbidities\n  * Other major disease that, under the PI's discretion, could interfere with the participant completing the study.\n* Concurrent serious illness including history of malignancy that could interfere with the study or a participant completing the study.\n* Known IgA deficiency\u002Fimmotile cilia syndrome\u002FKartagener's syndrome\n* Significant abnormality altering the anatomy\u002Ffunction of the nose or nasopharynx, a clinically significant history of epistaxis within the last 3 months, nasal\u002Fsinus surgery within 6 months of Day 0, including nasopharyngeal malignancy, arterio-venous malformation, or undiagnosed nasopharyngeal mass\n* Inhaled bronchodilator\u002Finhaled steroid use within the last 12 months before Day 0\n* Acute upper respiratory tract infection in the past 6 weeks.\n* Receipt of systemic glucocorticoids (in a dose ≥ 5 mg prednisone daily or equivalent) within one month, or any other cytotoxic or immunosuppressive drug within 6 months before Day 0\n* Receipt of any vaccine within 30 days of Day -14\n* Any significant medical condition\u002Fprescribed drug, under the PI's discretion\n* Presence of cold-like symptoms and\u002For fever on Day -14 or Day 0.\n* Receipt of blood\u002Fblood products\u002Floss (including blood donations) of 550 mL or more of blood during the 3 months prior to Day -14.\n* Significant history\u002Fpresence of drug\u002Falcohol misuse by self-report.\n* Current use of drugs through nose inhalation or inhaled route including recreational drugs.\n* Regular smoking and\u002For vaping and\u002For using nicotine-containing products in the past 3 months OR \\>5 pack-year lifetime history by self-report (5 pack years is equivalent to one pack of 20 cigarettes per day for 5 years).\n* History of anaphylaxis and\u002For a history of severe allergic reaction or significant intolerance to any food\u002Fdrug, as assessed by the PI.\n* Clinically active rhinitis (including hay fever)\u002Fhistory of moderate to severe rhinitis\u002Fhistory of seasonal allergic rhinitis likely to be active at the time of inclusion into the study and\u002For requiring regular nasal corticosteroids on an at least weekly basis, within 30 days of enrolment.\n* Anyone with any of the following contraindications to receiving the Fluenz Tetra Vaccine:\n\n  * Allergy to gentamicin, gelatin or the other ingredients of the fluenz vaccine.",{"count":122,"type":23},[176],"This experimental medicine study aims to compare immune responses in healthy adult volunteers aged 18-55 years against influenza vaccination and infection in the upper and lower respiratory tract, following administration of a live-attenuated influenza vaccine delivered by nasal spray versus influenza A (H3N2) viral challenge.",[29],[298,360,32,29,75],"Challenge","2026-04-15",{"date":363,"type":38},"2026-04-20",{"date":365,"type":38},"2025-04-16",{"date":367,"type":23},"2026-07-31",{"name":369,"class":255},"Imperial College London",{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":377,"enrollmentInfo":378,"targetDuration":4,"studyType":24,"phases":380,"briefSummary":381,"conditions":382,"keywords":383,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":85},"100581437","h5n1-milk-detection-study-100581437","NCT06850298","H5N1 Milk Detection Study","Investigation of Impact of Milk Consumption on H5 Influenza Detection in Respiratory Specimens","Inclusion Criteria:\n\n* Individuals aged 18-64 years\n* BMI ≤ 35 kg\u002Fm2\n* Able to understand and give informed consent (American English) and comply with study visits and procedures.\n* In good general health based on medical history and the investigator's clinical judgment.\n\nExclusion Criteria:\n\n* Symptoms of acute respiratory illness or conjunctivitis within 7 days\n* Febrile illness in the previous 72 hours\n* Recent influenza antiviral use (within 14 days)\n* Immunosuppression due to illness or medications\n* Current pregnancy or breastfeeding\n* History of allergy or intolerance to milk or milk alternatives\n* Consumption of raw (unpasteurized) milk within the previous 14 days\n* Recent work (within 14 days) on a farm with animals known to be infected with A(H5) virus\n* Previous receipt of A(H5) vaccine at any time","64 Years",{"count":379,"type":23},30,[176],"The purpose of this study is to determine whether drinking pasteurized milk (milk heated to kill harmful germs) that contains inactive particles of a flu virus called A(H5) could lead to the detection of the virus in the nose or throat. Inactive particles are not capable of causing disease. The results will help the Centers for Disease Control and Prevention (CDC) better understand how milk consumption could affect flu surveillance. Investigators also want to see if the body produces antibodies in response to this milk consumption.",[29],[384,385,386],"Pasteurized Milk","Flu Virus A (H5)","H5N1 avian influenza A","2026-04-13",{"date":361,"type":38},{"date":390,"type":38},"2025-05-09",{"date":392,"type":23},"2026-11",{"name":394,"class":255},"Emory University",{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":403,"enrollmentInfo":404,"targetDuration":4,"studyType":24,"phases":406,"briefSummary":407,"conditions":408,"keywords":409,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":256},"100489079","phase-2-a-phase-2-trial-comparing-antiviral-treatments-in-early-symptomatic-influenza-100489079","NCT05648448","A Phase 2 Trial Comparing Antiviral Treatments in Early Symptomatic Influenza","ADaptive ASsessment of TReatments for influenzA: A Phase 2 Multi-centre Adaptive Randomised Platform Trial to Assess Antiviral Pharmacodynamics in Early Symptomatic Influenza Infection (AD ASTRA)","AD ASTRA","Inclusion Criteria:\n\n* Patient understands the procedures and requirements and is willing and able to give informed consent for full participation in the study\n* Adults, male or female, aged 18 to 60 years at time of consent.\n* Early symptomatic Influenza (A or B); at least one reported symptom of influenza (including fever, history of fever, myalgias, headache, cough, fatigue, nasal congestion, rhinorrhoea and sore throat) within 4 days (96 hours)\n* Influenza positive by rapid antigen test OR a positive RT-PCR test for influenza viruses within the last 24hrs with a Ct value of \\\u003C30\n* Able to walk unaided and unimpeded in activities of daily living (ADLs)\n* Agrees and is able to adhere to all study procedures, including availability and contact information for follow-up visits\n\nExclusion Criteria:\n\nThe patient may not enter the study if ANY of the following apply:\n\n* Taking any concomitant medications or drugs which could interact with the study medications or have antiviral activity\n* Presence of any chronic illness\u002Fcondition requiring long term treatment or other significant comorbidity\n* BMI ≥35 Kg\u002Fm2\n* Clinically relevant laboratory abnormalities discovered at screening\n\n  * Haemoglobin \\\u003C10g\u002FdL\n  * Platelet count \\\u003C100,000\u002FuL\n  * ALT \\> 2x ULN\n  * Total bilirubin \\>1.5 x ULN\n  * eGFR \\\u003C70mls\u002Fmin\u002F1.73m2\n* For females: pregnancy, actively trying to become pregnant or lactation (healthy women on OCP are eligible to join)\n* Contraindication to taking, or known hypersensitivity reaction to any of the proposed therapeutics\n* Currently participating in another interventional influenza or COVID-19 therapeutic trial\n* Clinical evidence of pneumonia- e.g. shortness of breath, hypoxaemia, crepitations (imaging not required)\n* Known to be currently co-infected with SARS-CoV-2 (i.e. confirmed with positive ATK or RT-PCR)\n* Received live attenuated influenza virus vaccine within 3 weeks prior to study entry","60 Years",{"count":405,"type":23},3000,[26],"This trial will use a previously validated platform, to quantitatively assess antiviral effects in low-risk patients with high viral burdens and uncomplicated influenza, to determine in-vivo antiviral activity. In this randomised, open-label, controlled, group sequential, adaptive, platform trial, we will compare the performance of available influenza antivirals, and those with potential activity, relative to the control (no treatment) and each other.\n\nAD ASTRA study is supported by the Wellcome Trust Grant ref: 223195\u002FZ\u002F21\u002FZ through the COVID-19 Therapeutics Accelerator",[29,335],[29,410,411],"Phase 2","Antiviral Pharmacodynamics","2026-04-09",{"date":414,"type":38},"2026-04-14",{"date":416,"type":38},"2023-02-22",{"date":418,"type":23},"2027-01-01",{"name":420,"class":255},"University of Oxford",{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":17,"sex":18,"minAge":429,"maxAge":430,"enrollmentInfo":431,"targetDuration":4,"studyType":24,"phases":433,"briefSummary":434,"conditions":435,"keywords":436,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":46},"100503211","the-influential-trial--evaluation-of-national-inpatient-influenza-vaccination-program-100503211","NCT05832307","The INFLUENTIAL Trial- Evaluation of National Inpatient Influenza Vaccination Program","The INFLUENTIAL Trial - Inpatient FLU Vaccination Program Effectiveness: National Trial Implementing Best Practices and Learning Collaboratives","Influential","Inclusion Criteria:\n\n* At least 6 months of age\n* Admitted to an inpatient unit at a participating health system\n\nExclusion:\n\n\\- Admission to critical care sites or hematology-oncology services\n\nExclusion Criteria:\n\n* At least 6 months of age\n* Admitted to an inpatient unit at a participating health system\n\nExclusion:\n\n\\- Admission to critical care sites or hematology-oncology services","6 Months","99 Years",{"count":432,"type":23},22000,[176],"This study plans to learn more about whether a stakeholder-informed, standardized inpatient vaccination program will increase influenza vaccination rates of hospitalized children across US pediatric health systems. The first part of the study is to form a multidisciplinary team of stakeholders, including parents, providers, nurses, pharmacists, informaticists, data analysts and communication experts across three sites in synthesizing a best practice implementation guide for an inpatient influenza vaccination program, which will then be piloted at these three sites.",[29],[437,438],"vaccination","influenza","2026-04-07",{"date":441,"type":38},"2026-04-08",{"date":443,"type":38},"2024-10-31",{"date":445,"type":23},"2027-07-31",{"name":447,"class":255},"University of Colorado, Denver",{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":18,"minAge":320,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":69,"phases":4,"briefSummary":456,"conditions":457,"keywords":459,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":462,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":46},"100459715","respiratory-virus-sampling-and-repository-100459715","NCT05266222","Respiratory Virus Sampling and Repository","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Aged 3 years or older.\n2. Documented or suspected infection with a respiratory virus.\n3. Stated willingness to comply with all study procedures for the duration of the study.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1\\. Any condition that, in the opinion of the investigator, would compromise the safety of the study participant or staff, or would prevent proper conduct of the study.\n\nNon-English Speaking Participants: This study will enroll non-English speaking participants.\n\nFor non-English speaking participants, the study will be explained to the participant\u002Ffamily through an interpreter, in the presence of the study team, in the language understood by the participant\u002Ffamily. The short form in the language understood by the participant\u002Ffamily will be signed by the participant\u002Ffamily or LAR and the interpreter, and the consent will be signed by the consenting provider and the interpreter.",{"count":455,"type":23},20000,"Background:\n\nRespiratory viruses, like the flu or COVID-19, cause significant illness and death worldwide. Researchers want to collect samples from people with respiratory virus infections. The samples in this natural history study will be used in future research.\n\nObjective:\n\nTo obtain samples from people with respiratory viruses to learn more about respiratory virus infections and the immune responses against them.\n\nEligibility:\n\nPeople aged 3 and older who have or are suspected to have a respiratory virus infection.\n\nDesign:\n\nParticipants will be screened with a medical record review.\n\nParticipants will give blood samples. Data from their medical records will be collected.\n\nParticipants will give nose samples. A soft plastic strip will be put into each nostril for a minute. They may also give nose, mouth (back of the throat), or saliva samples using swabs.\n\nParticipants may receive kits by mail to collect nose and blood samples at home. They will use soft plastic strips to collect nose samples. To collect blood, they will prick their finger and dab a few drops of blood on four plastic tips.\n\nIf a participant is in the hospital, air samples may be collected in their room.\n\nParticipation will last for up to 2 years. After 2 years, participants may be asked for their consent again to give new samples and new medical data.",[29,458],"COVID-19",[29,75,460,97,461,104],"COVID","Immunity",{"date":441,"type":38},{"date":464,"type":38},"2022-08-11",{"date":466,"type":23},"2031-12-31",{"name":44,"class":45},{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":474,"enrollmentInfo":475,"targetDuration":4,"studyType":69,"phases":4,"briefSummary":477,"conditions":478,"keywords":479,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":482,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":85},"100423513","natural-history-of-systemic-and-nasal-mucosal-immunity-to-influenza-and-sars-cov-2-in-adults-after-vaccination-100423513","NCT04794829","Natural History of Systemic and Nasal Mucosal Immunity to Influenza and SARS-CoV-2 in Adults After Vaccination","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. NIH staff members, at the time of enrollment.\n2. Able to provide informed consent.\n3. \\>=18 years of age.\n4. Planning to receive the current influenza season s vaccine and\u002For an FDA-authorized or approved SARS-CoV-2 vaccine.\n5. Willing and able to undergo blood draws or home blood samplings and nasal sampling procedures.\n6. Willing and able to undergo at least one blood draw and one nasal sampling prior to receiving vaccine.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Already received the current season s influenza vaccine and does not plan to receive an FDA-authorized or approved SARS CoV-2 vaccine.\n2. Already received an FDA-authorized or approved SARS-CoV-2 vaccine and does not plan to receive the current season s influenza vaccine.\n3. Not willing to receive the current influenza season's vaccine and not willing to receive an FDA-authorized or approved SARS-CoV-2 vaccine.\n4. Any condition that, in the opinion of the investigator, contraindicates participation in this study.\n\nCo-enrollment guidelines: Participants may be co-enrolled in other studies; however, study staff should be notified of co-enrollment.","120 Years",{"count":476,"type":23},150,"Background:\n\nInfluenza (flu) vaccinations are required for all NIH staff members who have direct contact with patients. COVID-19 vaccines are recommended for persons 6 months of age and older. Researchers want to learn about immunity in NIH staff members who get a flu and\u002For COVID-19 vaccine.\n\nObjective:\n\nTo understand what happens to the body s immune system throughout the year after getting the flu and\u002For COVID-19 vaccine.\n\nEligibility:\n\nAdults ages 18 and older who work at NIH and plan to get the current season s flu vaccine and\u002For COVID-19 vaccine.\n\nDesign:\n\nParticipants will not get any vaccines as part of this study.\n\nParticipants will be screened with a medical history and medicine review. They will get a survey via email. It will ask about their flu and SARS-CoV-2 history and vaccinations.\n\nParticipants will have 12 monthly visits at NIH. If during that year they get both flu and SARS-COV-2 vaccines, their participation will be extended.\n\nOnce a month, participants will be contacted. They will discuss any new medicines, recent vaccinations, or changes in medical history.\n\nOnce a month, participants will have blood drawn.\n\nOnce a month, participants will have nasal sampling. A small, flat absorptive strip will be placed in the nostril to soak up mucus. Participants will press against the outside of their nostril with their finger for 1 minute.\n\nParticipants may be able to collect samples at home and mail them to NIH if they are not able to visit in person.\n\nParticipation will last for about 12 13 months.",[29,458],[75,480,331,481,458,104],"Antibody","Pandemic",{"date":441,"type":38},{"date":484,"type":38},"2021-08-19",{"date":486,"type":23},"2026-12-31",{"name":44,"class":45},{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":4,"eligibilityCriteria":494,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":24,"phases":497,"briefSummary":498,"conditions":499,"keywords":500,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":122},"100631113","phase-3-a-study-of-mrna-1018-h5-pandemic-influenza-vaccine-in-healthy-adults-100631113","NCT07496450","A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults","A Phase 3, Randomized, Observer-blind, Placebo-controlled Study to Evaluate the Immunogenicity, Safety, and Reactogenicity of mRNA-1018-H5 Pandemic Influenza Vaccine in Adults ≥18 Years of Age","Key Inclusion Criteria:\n\n* Healthy as determined by medical evaluation including medical history; and physical examination. Participants with clinically stable chronic medical conditions are permitted.\n* Participants who are assigned female at birth or could become pregnant are eligible to participate if the participant is not pregnant or breast\u002Fchest feeding, and one of the following conditions applies:\n\n  * Is a person of nonchildbearing potential (PONCBP) OR\n  * Is a person of childbearing potential (POCBP)\n  * A POCBP must have a negative highly sensitive pregnancy test at Screening and on the day of the first dose of study intervention.\n\nKey Exclusion Criteria:\n\n* Participant is acutely ill or febrile (body temperature ≥ 38.0 degrees Celsius \\[°C\\]\u002F100.4 degrees Fahrenheit \\[°F\\]) within 72 hours prior to or at the Screening Visit or Day 1.\n* History of myocarditis, pericarditis, or myopericarditis.\n* History of Guillain-Barre syndrome.\n* Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections disease.\n* Treated with antiviral therapies for influenza (eg, Tamiflu, Xofluza) within 28 days prior to Day 1.\n* Prior receipt of a pandemic influenza vaccine or participation in any pandemic influenza vaccine clinical study, including the mRNA-1018-P101 study.\n* Any medical, psychiatric, or occupational condition, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with adherence to study procedures or the interpretation of study results.\n* Participant has received systemic immunosuppressants including long-acting biological therapies that affect immune responses (eg, infliximab, methotrexate, omalizumab, etc.), within 180 days prior to Screening or plans to do so at any time during participation in the study.\n* Participant has received corticosteroids at ≥10 mg\u002Fday of prednisone or equivalent for \\>14 days in total within 90 days prior to Day 1 (Baseline) or is anticipating the need for corticosteroids at any time during the study.\n* Participants has received any licensed vaccine authorized or approved by local health agency including mRNA vaccine ≤28 days prior to study intervention (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 21 days after the study intervention.\n* Participant has participated in an interventional clinical study within 90 days prior to the Screening visit based on the medical history interview or plans to do so while participating in this study.\n\nNote: Other inclusion\u002Fexclusion criteria may apply.",{"count":496,"type":23},4000,[270],"The purpose of this study is to evaluate humoral immunogenicity after 2 doses of mRNA-1018-H5, and to evaluate the safety and reactogenicity of mRNA-1018-H5 in adults ≥18 years of age.",[29],[501,502,503,504,505,506,507,508,509],"Influenza Vaccine","Moderna","mRNA-1018-H5","Viral Diseases","Vaccines","Pandemic Influenza","Avian Flu","Bird Flu","Influenza A","2026-04-02",{"date":512,"type":38},"2026-04-03",{"date":514,"type":38},"2026-03-23",{"date":516,"type":23},"2027-01-28",{"name":518,"class":137},"ModernaTX, Inc.",{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":526,"targetDuration":4,"studyType":24,"phases":528,"briefSummary":529,"conditions":530,"keywords":531,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":536,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":46},"100601441","phase-1-ph1n1-blinded-challenge-study-100601441","NCT07110532","pH1N1 Blinded Challenge Study","A Double-Blinded, Randomized Influenza Virus Challenge Trial of Recombinant Influenza RG-A\u002FArkansas\u002F08\u002F2020 (pH1N1) in Healthy Adults to Assess Safety and Optimal Infectious Dose","Inclusion Criteria:\n\n1. Provides signed and dated informed consent form prior to the initiation of any trial procedures.\n2. Able to understand and agrees to comply with all planned trial procedures and to be available for all study visits.\n3. Age \\>\u002F= 18 and \\\u003C\u002F= 55 years at time of enrollment.\n4. Must agree to collection of venous blood and nasal absorption specimens per protocol and enrollment in DMID 19-0025 biorepository protocol for use of residual\u002Frepository research blood specimens.\n5. In good general health.\\*\n\n   \\*Good health, as determined by medical history, medication use and physical examination to evaluate ongoing chronic medical or psychiatric diagnoses or conditions, defined as those that have been present for at least 90 days, which would not affect the assessment of the safety of participants or the immunogenicity of challenge. These medical diagnoses or conditions should be stable for the last 90 days -- no hospitalizations, emergency room or urgent care for condition (excluding musculoskeletal conditions). If a participant has an ongoing symptomatic condition for which they have had or have ongoing medical investigations but have not yet received a diagnosis or treatment plan, they may not be in good health, as determined by the site PI or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572. Participants may be on a medical intervention (such as device or medication) only if the condition or disease being treated is stable and not deteriorating, the medications are not listed in the Exclusion Criteria and treatment poses no additional risk to participant safety or assessment of adverse events. This also includes no change in prescription medication, dose, or frequency as a result of new symptoms or deterioration of the condition or disease being treated in the 30 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a condition or disease outcome (e.g., lowering of the dosage or frequency), as determined by the site Principal Investigator (PI) or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572, will not be considered a deviation of this inclusion criterion.\n6. Able to take oral medication and willing to receive oseltamivir phosphate and\u002For baloxavir marboxil as part of the study.\n7. Participants of childbearing potential\\* agree to the use of acceptable forms of contraception\\*\\* for at least 30 days prior to enrollment and agree to use such a method during study participation.\n\n   \\*Childbearing potential in a participant is defined as not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure(R) placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or \\\u003C1 year since last menses if menopausal.\n\n   \\*\\*Acceptable forms of primary contraception include true abstinence (100% of time no insertional sexual intercourse), or, if heterosexual intercourse is anticipated, monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to enrollment, intrauterine devices, birth control pills, condoms, and injectable\u002Fimplantable\u002Finsertable\u002Ftransdermal hormonal birth control products. Must use at least one acceptable form of contraception for at least 30 days prior to enrollment and through study completion.\n8. Non-smoker or non-habitual smoker\\* of tobacco, e-cigarettes, or marijuana\n\n   \\*A non-habitual smoker is a person who smokes no more than four cigarettes, other tobacco products, e-cigarettes (to include vaping and Juul products), and\u002For marijuana in a week.\n9. No self-reported or known history of alcoholism within the 2 years prior to enrollment.\n10. No self-reported or known history of illicit drug use for at least 30 days prior to enrollment.\n11. Agrees not to use the listed prescription or over the counter medications\\* within 7 days prior to confinement and through the confinement period\\*\\*.\n\n    \\*Oseltamivir, zanamivir, peramivir, baloxavir marboxil, amantadine, rimantadine, aspirin, intranasal steroids, decongestants, antihistamines, and non-steroidal anti-inflammatory drugs (NSAIDs)\n\n    \\*\\*An exception can be made with the approval of the site PI or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572\n12. Screening pulse is 55 to 100 beats per minute, inclusive\\*\n\n    \\*Screening pulse values in the normal range or with grade 1 abnormalities deemed not clinically significant by the site PI or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572 are considered acceptable.\n13. Screening systolic blood pressure is 90 to 140 mmHg, inclusive\\*\n\n    \\*Screening systolic blood pressure values in the normal range or with grade 1 abnormalities deemed not clinically significant by the site PI or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572 are considered acceptable.\n14. Screening diastolic blood pressure is 55 to 90 mmHg, inclusive\\*\n\n    \\*Screening diastolic blood pressure values in the normal range or with grade 1 abnormalities deemed not clinically significant by the site PI or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572 are considered acceptable.\n15. Screening SpO2 \\>\u002F= 95 percent\n16. Screening respiratory rate is \\\u003C\u002F= 16\n17. Screening oral temperature is \\\u003C100.4 degrees Fahrenheit\n18. Screening body mass index (BMI) \\>\u002F=18.5 and \\\u003C40 kg\u002Fm\\^2 at screening 19 Screening\n19. Screening lab test results are within acceptable parameters:\\*\n\n    * White blood cell (WBC), Absolute lymphocyte count (ALC), Hemoglobin (Hgb), Platelet (PLT). Lab tests within normal range or with grade 1 abnormalities deemed not clinically significant by the site PI or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572 are considered acceptable.\n    * Alanine transferase (ALT), Aspartate Aminotransferase (AST), Gamma-Glutamyl Transferase, Alkaline Phosphatase (ALP), Total Bilirubin, and Creatinine (Cr). Low values are acceptable for trial inclusion as they are not considered to be clinically significant.\n20. Has a negative test result for hepatitis B surface antigen, hepatitis C virus antibody\\*, or HIV types 1 or 2 antibodies at screening.\n\n    \\*Persons testing positive for hepatitis C virus antibody with a history of treatment and a negative HCV viral load may be acceptable in the opinion of the site PI or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572.\n21. Electrocardiogram (ECG) and chest X-ray (CXR) at screening are within normal range or are not deemed clinically significant\\*\n\n    \\*As determined by the site PI or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572.\n22. Negative respiratory virus panel (including influenza A and B, and SARS-CoV-2) by certified polymerase chain reaction (PCR)-based assay on Day -2 and Day -1.\n23. Agrees to remain in the confinement unit for at least 6 days after enrollment and until they meet discharge criteria.\n24. Agrees to adhere to lifestyle considerations during the study. Note: Deviations of lifestyle considerations will be reported as protocol deviations but not as eligibility deviations.\n\nExclusion Criteria:\n\n1. A history (self-reported or medically documented) of medical or psychiatric condition(s)\\* or physical exam finding that precludes participation.\n\n   * Any condition that, in the opinion of the site PI or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572, might interfere with the safety of the participant and\u002For study objectives including, but not limited to the following:\n   * Respiratory disease (e.g., chronic obstructive pulmonary disease \\[COPD\\], asthma) requiring daily medications (Inhaled, oral, or intravenous corticosteroids, leukotriene modifiers, long and short acting beta agonists, theophylline, ipratropium, biologics) or any treatment for respiratory disease exacerbations (e.g., asthma exacerbation) within the last 5 years\n   * Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis as an adult\n   * Neurological or neurodevelopmental conditions (e.g., epilepsy, stroke, encephalopathy, Guillain-Barre syndrome, encephalomyelitis, or transverse myelitis). A history of febrile seizures during childhood alone is not diagnostic of epilepsy.\n   * Anatomic or neurologic abnormality impairing the gag reflex or contributing to aspiration\n   * Significant abnormality altering anatomy of nose\u002Fnasopharynx (including significant nasal polyps), clinically significant nasal deviation, nasal\u002Fsinus surgery within 180 days prior to enrollment, spontaneous epistaxis requiring medical care within 180 days prior to enrollment, chronic or recurrent sinusitis (four or more distinct episodes of sinusitis, with symptom-free intervals between episodes) in the last year prior to enrollment\n   * Significant immunodeficiency\n   * Known infection by human immunodeficiency virus (HIV) or hepatitis B virus, or known untreated hepatitis C virus infection\n   * Ongoing malignancy or diagnosis of malignancy in the last five years (excluding squamous cell or basal cell carcinoma of the skin)\n   * Diabetes\n   * Blood dyscrasias or significant disorder of coagulation\n2. HAI antibody titer \\>1:40 against influenza A\u002FArkansas\u002F08\u002F2020 (pH1N1) at screening\n3. Current or within 4-month use of medications that may be associated with impaired immune responsiveness\\* \\*Including, but not limited to, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or systemic corticosteroids (i.e., exceeding 14 days of use and\u002For exceeding 10 mg\u002F day prednisone equivalent) or other similar or toxic drugs during the preceding 3-month period prior to screening. Low dose systemic corticosteroids (10mg\u002Fday or lower of prednisone) for 14 days or fewer are permitted. Low dose topical and intranasal steroid preparations are allowed, if not within 7 days of challenge or during the confinement period.\n4. Current pregnancy\\* or lactation\n\n   \\*Participants of childbearing potential must have a negative serum pregnancy test at screening, a negative urine pregnancy test after admission to the confinement unit but before challenge, and a negative pregnancy test before any CXR (if \\>\u002F= 7 days have passed since a serum pregnancy test).\n5. Presence of an internal cardiac device such as a pacemaker or other implanted electronic medical devices\n6. Has received blood or blood products in the last six months or has plans to donate blood or blood products in the duration of the study\n7. History of a previous severe allergic reaction to any drug or biologic with generalized urticaria, angioedema, or anaphylaxis\n8. Allergy or intolerance to treatments for influenza (including any neuraminidase inhibitors or baloxavir marboxil)\n9. Allergy to two or more classes of antibiotics (e.g., penicillins, cephalosporins, fluoroquinolones, or glycopeptides)\n10. Allergy to excipients in the challenge virus inoculum\n11. Presence of any febrile illness or symptoms suggestive of a respiratory infection at the time of enrollment, the time of confinement, or Day 1 pre-challenge\n12. Close contact with anyone known or suspected to have a respiratory viral illness within 7 days prior to enrollment\n13. Currently enrolled in any other investigational study or plans to enroll in any other study within the period of this study\\*\n\n    \\*Co-enrollment in an observational study, an investigational study in a follow-up\u002Fpost vaccination stage, or a study involving a licensed drug or biologic may be allowed at the discretion of the site PI or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572.\n14. Received any live vaccine in the 4 weeks prior to enrollment.\n15. Received any influenza vaccine in the 4 months prior to enrollment or plans to receive influenza vaccine during the study",{"count":527,"type":23},90,[124],"This protocol describes a clinical trial to develop and validate a Controlled Human Infection Model (CHIM) for influenza A\u002FArkansas\u002F08\u002F2020 (pH1N1). The study is designed to determine the optimal infectious dose of the pH1N1 challenge strain for use in future clinical trials evaluating influenza countermeasures. The study will enroll and challenge adult volunteers with the pH1N1 influenza virus challenge or sham inoculations. Given the adaptive design of this trial, the potential number of participants can vary. Depending on the pathway recommended by the PSRT and followed in the Trial Schema, the study population can range from around 30 to 99. The anticipated final sample size will be approximately 90 receiving pH1N1 challenge product plus and 6 persons receiving a sham inoculation. Participants will be pre-screened for health and for serological HAI antibody titers of \\\u003C\u002F1:40 against the challenge strain. Eligible participants will be enrolled sequentially into challenge cohorts and will be randomly assigned to receive a single dose of either sham inoculation or the interventional study product at a dose between 10\\^6 to 10\\^7 TCID50 (or 10\\^5 TCID50 if needed). Dose titration will be conducted under an adaptive escalation schedule whereby dosing will start at 10\\^6 TCID50 and escalate to the next dose if a pre-determined symptomatic influenza attack rate and clinical symptom score thresholds are not met and if the dose is determined to be safe with no pre-defined halting criteria being met.\n\nThe primary objectives of this study are to determine the optimal infectious dose of a pH1N1 viral challenge to cause laboratory-confirmed clinical influenza and to assess the safety profile of pH1N1 viral challenge.",[29],[532,533,29,509,534,535],"challenge","Double-blind","pH1N1","Random",{"date":441,"type":38},{"date":538,"type":38},"2025-09-10",{"date":540,"type":23},"2026-08-18",{"name":44,"class":45},{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":4,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":18,"minAge":549,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":24,"phases":552,"briefSummary":553,"conditions":554,"keywords":556,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":564,"completionDateStruct":565,"leadSponsor":566,"locationsCount":85},"100632691","noseguard-for-prevention-of-respiratory-infections-in-real-world-use-100632691","NCT07516977","Noseguard for Prevention of Respiratory Infections in Real-World Use","A Clinical Study to Evaluate the Effectiveness of Combined Use of Two Nasal Protective Medical Devices (Noseguard and Noseguard Night) for Reducing Respiratory Infection Rates and Assessing Usability","Inclusion Criteria:\n\n* Adults aged ≥19 years\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Hypersensitivity to device components\n* Current COVID-19 or influenza infection\n* Severe nasal disease\n* Pregnant or breastfeeding women","19 Years",{"count":551,"type":23},2000,[176],"This study is a prospective clinical study to evaluate the effectiveness of combined use of two nasal protective medical devices (Noseguard and Noseguard Night) in reducing respiratory infection rates, including COVID-19 and influenza, in real-world conditions.\n\nThe study will also assess usability, satisfaction, and safety using electronic patient-reported outcomes (ePRO).",[555,458,29],"Respiratory Infection Virus",[557,558,559,560,561],"Nasal Spray","Medical Device","Infection prevention","ePRO","Real-World","2026-04-01",{"date":441,"type":38},{"date":363,"type":23},{"date":486,"type":23},{"name":567,"class":137},"Daewoong Pharmaceutical Co. LTD.",{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":4,"eligibilityCriteria":574,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":575,"targetDuration":4,"studyType":24,"phases":577,"briefSummary":578,"conditions":579,"keywords":580,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":586,"leadSponsor":588,"locationsCount":85},"100631647","phase-2-phase-2a-study-of-the-efficacy-and-safety-of-trx-100-in-a-human-influenza-a-challenge-model-100631647","NCT07503405","Phase 2a Study of the Efficacy and Safety of TRX-100 in a Human Influenza A Challenge Model","A Phase 2a, Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tivoxavir Marboxil (TRX-100) in Healthy Adults in a Human Influenza A Challenge Model","Inclusion Criteria:\n\n1. Written informed consent signed and dated by the participant and the PI\u002Finvestigator obtained before any assessment is performed.\n2. Aged between 18 and 55 years old on the day prior to signing the consent form, inclusive.\n3. A total body weight ≥50 kg and body mass index (BMI) ≥18 kg\u002Fm2 and ≤35kg\u002Fm2.\n4. In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, (including vital signs), ECG, and routine laboratory tests as determined by the PI\u002Finvestigator.\n5. Participants will have a documented medical history either prior to entering the study or following medical history review with the study physician at screening.\n6. The following criteria are applicable to female participants participating in the study:\n\n   1. Females of childbearing potential must have a negative pregnancy test prior to enrollment.\n   2. Females of non-childbearing potential:\n\n   \u003C!-- -->\n\n   1. Postmenopausal females defined as amenorrhea for 12 months or greater with no alternative medical cause. A high follicle-stimulating hormone (FSH) level, within appropriate postmenopausal range, may be used to confirm postmenopausal state in the absence of combined hormonal contraception or hormone replacement therapy. If there is less than 12 months of amenorrhea 2 FSH samples are required at least 4 to 6 weeks apart.\n   2. Documented status as being permanently sterile (e.g., hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).\n7. Female participants of childbearing potential must use one form of highly effective contraception (birth control). Hormonal methods must be in place from at least 2 weeks prior to the first study visit (IMP administration visit). The contraception use must continue until 28 days after the date of challenge agent administration.\n\n   Male participants must agree to use one of the contraceptive requirements below from the first study visit and continuing until 28 days after the date of challenge agent administration.\n8. Serosuitable for the challenge agent. The serology result obtained from the influenza antibody assay suggests that the participant is sensitive to influenza infection (i.e., they are likely to be infected following inoculation with the challenge agent).\n\nExclusion Criteria:\n\n1. History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (URT or LRT) infection within 4 weeks prior to the first study visit.\n2. Any history or evidence of any clinically significant or currently active cardiovascular, respiratory, dermatological, gastrointestinal, endocrinological, hematologic, hepatic, immunological (including immunosuppression), metabolic, urological, renal, neurological, or psychiatric disease and\u002For other major disease that, in the opinion of the PI\u002Finvestigator, may interfere with a participant completing the study and necessary investigations. The following conditions apply:\n\n   1. Participants with a history of resolved depression and\u002For anxiety may be included at the discretion of the PI\u002Finvestigator. Participants with a history of stress-related illness, which is not ongoing or requiring current therapy, with good evidence of preceding stressors may also be included at the PI\u002Finvestigator's discretion. As required, participants will be assessed prior to enrollment with a Patient Health Questionnaire (PHQ)-9 and\u002For Generalized Anxiety Disorder (GAD)-7 questionnaire which must score ≤4 on admission.\n   2. Rhinitis (including hay fever) which is clinically active or a history of moderate to severe rhinitis, or history of seasonal allergic rhinitis likely to be active at the time of inclusion into the study and\u002For requiring regular nasal corticosteroids on an at least weekly basis, within 30 days of admission to quarantine will be excluded. Participants with a history of currently inactive rhinitis (within the last 30 days) or mild rhinitis may be included at the PI\u002Finvestigator's discretion.\n   3. Atopic dermatitis\u002Feczema which is clinically severe and\u002For requiring moderate to large amounts of daily dermal corticosteroids will be excluded. Participants with mild to moderate atopic dermatitis\u002Feczema, taking small amounts of regular dermal corticosteroids may be included at the PI\u002Finvestigator's discretion.\n   4. Any concurrent serious illness including history of malignancy that may interfere with a participant completing the study. Basal cell carcinoma within 5 years of initial diagnosis or with evidence of recurrence is also an exclusion.\n   5. Participants reporting physician-diagnosed migraine can be included provided there are no associated neurological symptoms such as hemiplegia or visual loss. Cluster headache\u002Fmigraine or prophylactic treatment for migraine is an exclusion.\n   6. Participants with physician-diagnosed mild irritable bowel syndrome not requiring regular treatment can be included at the PI\u002Finvestigator's discretion.\n3. Any participants who have smoked ≥10 pack years at any time (10 pack years is equivalent to one pack of 20 cigarettes a day for 10 years) including (as applicable) any calculable or self-reported significant vaping history.\n4. Females who:\n\n   1. Are breastfeeding, or\n   2. Have been pregnant within 6 months prior to the study, or\n   3. Have a positive pregnancy test at any point during screening or prior to dosing with IMP.\n5. Lifetime history of anaphylaxis and\u002For a lifetime history of severe allergic reaction. Significant intolerance to any food or drug in the last 12 months, as assessed by the PI\u002Finvestigator.\n6. Venous access deemed inadequate for the phlebotomy and cannulation demands of the study.\n7. a) Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and, in particular, any of the nasal assessments or challenge agent administration (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and\u002For requiring regular treatments in the last month will be excluded).\n\n   b) Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months of the first study visit and\u002For history of being hospitalized due to epistaxis on any previous occasion.\n\n   c) Any nasal or sinus surgery within 3 months of the first study visit.\n8. a) Evidence of vaccinations within the 4 weeks prior to the planned date of dosing with IMP.\n\n   b) Intention to receive any vaccination(s) before the last day of follow-up. c) Receipt of influenza vaccine in the last 180 days prior to the planned date of viral challenge.\n\n   d) Received antiviral medication for influenza in the last 180 days prior to the planned date of viral challenge.\n\n   e) Having had confirmed influenza illness in the last 180 days prior to the planned dosing of IMP.\n9. Receipt of blood or blood products, or loss (including blood donations) of 550 mL or more of blood during the 3 months prior to the planned date of dosing with IMP or planned during the 3 months after the final follow-up visit.\n10. a) Receipt of any investigational drug within 3 months or 5 half-lives (whichever is greater) prior to the planned date of dosing with IMP.\n\n    b) Receipt of ≥3 investigational drugs within the previous 12 months prior to the planned date of dosing with IMP.\n\n    c) Prior inoculation with a virus from the same virus-family as the challenge agent.\n\n    d) Prior participation in another human challenge study with a challenge agent in the preceding 3 months, taken from the date of challenge agent administration in the previous study to the date of expected challenge agent administration in this study.\n11. Use or anticipated use during the conduct of the study of concomitant medications (prescription and\u002For non-prescription), including vitamins or herbal and dietary supplements within the specified windows, unless in the opinion of the PI\u002Finvestigator, the medication will not interfere with the study procedures or compromise participant safety. Specifically, the following are excluded:\n\n    1. Herbal supplements within 7 days prior to the planned date of dosing with IMP.\n    2. Chronically used medications, vitamins, or dietary supplements, including any medications known to be potent inducers or inhibitors of CYP450 enzymes, within 21 days prior to the planned date of dosing with IMP.\n    3. Over the counter medications (e.g., paracetamol or ibuprofen) where the dose taken over the preceding 7 days prior to the planned date of dosing with IMP has exceeded the maximum permissible 24-hour dose (e.g., ≥4 g paracetamol over the preceding week).\n    4. Systemic antiviral administration within 4 weeks of the dosing with IMP.\n12. a) Confirmed positive test for drugs of misuse on first study visit (i.e., IMP administration visit). One repeat test is allowed at PI\u002Finvestigator's discretion.\n\n    b) Recent history or presence of alcohol addiction, or excessive use of alcohol (weekly intake in excess of 28 units alcohol; 1 unit being a half glass of beer, a small glass of wine or a measure of spirits).\n\n    c) Excessive consumption of xanthine-containing substances (e.g., daily intake in excess of 5 cups of caffeinated drinks e.g., coffee, tea, cola).\n\n    d) Presence of significant signs and symptoms of nicotine withdrawal on entry to the clinical unit.\n13. A forced expiratory volume in 1 second (FEV1) \\\u003C 80%.\n14. Positive HIV, hepatitis B, or hepatitis C test.\n15. Presence of fever, defined as participant presenting with a temperature reading of ≥37.9ºC on Day -2, Day -1, and\u002For pre-challenge on Day 0.\n16. Those employed or immediate relatives of those employed at hVIVO or the sponsor.\n17. Any other medical, psychiatric, social, or occupational condition and\u002For responsibility that, in the opinion of the PI\u002Finvestigator, would interfere with, or serve as a contraindication to, protocol adherence or the assessment of safety (including reactogenicity) will deem the participant unsuitable for the study.\n\nAny other reason that in the opinion of the PI\u002Finvestigator raises a concern that the participant will not be able to cope with quarantine requirements.",{"count":576,"type":23},165,[26],"This will be a randomized, double-blind, placebo-controlled proof of concept study to evaluate the prophylactic efficacy and safety of orally administered TRX-100 in healthy adults challenged with influenza A\u002FFrance\u002F759\u002F2021 (H1N1) virus.",[29],[581],"Challenge study","2026-03-25",{"date":584,"type":38},"2026-03-31",{"date":184,"type":23},{"date":587,"type":23},"2027-04",{"name":589,"class":137},"Traws Pharma, Inc.",{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":594,"acronym":4,"eligibilityCriteria":595,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":289,"enrollmentInfo":596,"targetDuration":4,"studyType":24,"phases":598,"briefSummary":599,"conditions":600,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":46},"100464838","phase-1-influenza-human-challenge-model-100464838","NCT05332899","Influenza Human Challenge Model","Inclusion Criteria:\n\n* Provide written informed consent prior to initiation of any study procedures.\n* Are able to understand and comply with all planned study procedures.\n* Healthy males and non-pregnant, non-breast-feeding females aged ≥18 and ≤49 years of age inclusive at enrollment.\n* Women of childbearing potential must be practicing abstinence or using an acceptable method of birth control for at least 30 days prior to enrollment through the duration of the trial. Male subjects must agree not to father a child for the duration of the trial.\n* Women of childbearing potential must have a negative serum or urine pregnancy test at screening and negative urine pregnancy test within 24 hours prior to challenge.\n* Are in good general health, as determined by the study investigator within 30 days of challenge and do not have any of the following conditions:\n\n  * Chronic pulmonary disease (e.g., asthma or reactive airway disease, emphysema)\n  * Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects)\n  * Chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years (e.g., diabetes mellitus, renal dysfunction, hemoglobinopathies)\n  * Immunosuppression or ongoing malignancy or history of malignancy (excluding nonmelanotic skin cancer in remission without treatment for more than 5 years)\n  * Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures)\n  * History of postinfectious or postvaccine neurological sequelae\n  * Autoimmune, inflammatory, vasculitic or rheumatic disease, including but not limited to systemic lupus erythematosus, polymyalgia rheumatica, rheumatoid arthritis or scleroderma\n* Demonstrate knowledge and comprehension of the study by scoring ≥70% on a quiz of the study protocol and policies.\n* Agrees to not use cigarettes, e-cigarettes, marijuana, or other tobacco products during the quarantine period.\n* Agrees to not use prescription or over-the-counter medications that could impact influenza challenge efficacy or symptoms (including oseltamivir, zanamivir, peramivir, baloxavir marboxil, amantadine and rimantadine, aspirin, intranasal steroids, acetaminophen, decongestants, antihistamines, and other NSAIDs), within 14 days prior to quarantine and through the quarantine period, unless approved by the investigator.\n\nExclusion Criteria:\n\n* Have household contact with or have daily contact with:\n\n  * Children under 5 years of age\n  * Children and\u002For teenagers who are receiving long-term aspirin therapy\n  * Women who are pregnant or who are trying to become pregnant\n  * Persons older than 65 years of age\n  * Persons of any age with significant chronic medical conditions such as: chronic pulmonary disease, chronic cardiovascular disease, contacts who required medical follow-up or hospitalization during the past 5 years because of chronic metabolic disease, immunosuppression or cancer, neurological and neurodevelopmental conditions\n* Are healthcare workers with patient contact in the 2 weeks after influenza challenge.\n* Plan to be living in a confined environment (e.g. ship, camp, or dormitory) within 2 weeks after receiving the challenge strain.\n* For females, are pregnant or plan to become pregnant at any time between the Screening Visit through the duration of the trial.\n* Are breastfeeding or plan to breastfeed at any given time throughout the study.\n* Have a body mass index (BMI) less than or equal to 18.5 and greater than or equal to 35.\n* Smoke more than 4 cigarettes, e-cigarettes, marijuana, or other tobacco products on weekly basis within 60 days prior to challenge.\n* Have moderate or severe illness and\u002For an oral temperature ≥100°F and\u002For diarrhea or vomiting within seven days prior to challenge.\n* Have a pulse rate less than 55 beats per minute (bpm) or \\>100 bpm. If heart rate is \\\u003C55 bpm and the investigator determines that this is not clinically significant (e.g., athletes) and heart rate increases \\>55 bpm on moderate exercise (two flights of stairs), subject will not be excluded.\n* Have a systolic blood pressure less than 90 mmHg or greater than 140 mmHg on two separate measurements (screening and pre-challenge).\n* Have a diastolic blood pressure less than 50 mmHg or greater than 90 mmHg on two separate measurements (screening and pre-challenge).\n* Have long-term (≥2 weeks) use of high-dose oral (≥20 mg per day prednisone or equivalent) or parenteral glucocorticoids, or high-dose inhaled steroids for greater than 7 days in the last 3 months.\n* Have an active HIV, hepatitis B, or hepatitis C infection.\n* Have screening laboratory test results (white blood cells (WBCs), absolute neutrophil count (ANC), hemoglobin (Hgb), platelets) that are outside the laboratory reported normal values and deemed clinically significant by the study investigator.\n* Have a serum creatinine greater than 1.1 x upper limit of normal (ULN).\n* Have an alanine aminotransferase (ALT) greater than 1.1 x ULN.\n* Have abnormal findings on screening electrocardiogram deemed clinically significant by study investigator.\n* Have abnormal findings on screening chest X-ray deemed clinically significant by study investigator.\n* Have ongoing drug abuse\u002Fdependence (including alcohol), or a history of these issues within 5 years of enrollment.\n* Have positive urine\u002Fserum test for drugs of abuse (i.e. cocaine, benzodiazepines, opiates, or metabolites). Positive results for tetrahydrocannabinol (THC) will not be considered exclusionary. Metabolites and amphetamines as prescribed for a documented medical condition will also not be considered exclusionary.\n* Have any medical, psychiatric, occupational, or behavioral problems that could make it difficult for the subject to comply with the protocol as determined by the investigator.\n* Have received experimental products within 30 days before study entry or plan to receive experimental products at any time during the study.\n* Plans to enroll in another clinical trial that could interfere with safety assessment of the investigational product at any time during the study period, including study interventions such as drugs, biologics or devices.\n* Plan to donate blood during the course of the study.\n* Have received a live vaccine within 30 days before study entry or plan to receive a live vaccine prior to Day 31 of the challenge.\n* Have received an inactivated vaccine within 14 days before study entry or plan to receive an inactivated vaccine prior to Day 14 of the challenge.\n* Have received parenteral immunoglobulin or blood products within 3 months of the study start, or plan to receive parenteral immunoglobulin or blood products for the duration of the study.\n* Have a known close contact with anyone known to have influenza in the past 7 days prior to screening or challenge.\n* Have a known history of allergy to anti-influenza drugs, more than 2 classes of antibiotics or severe egg allergy.\n* Have any condition that, in the judgment of the study investigator, is a contraindication to protocol participation or impairs the subject's ability to give informed consent.\n* Have a BIOFIRE® FILMARRAY® respiratory panel that identifies any pathogen on the day of admission.\n* Clinically significant abnormality as deemed by the study investigator on the PFT and\u002For spirometry at screening visit (if applicable, for inhalation challenge only.)",{"count":597,"type":23},80,[124],"This study examines how the immune system responds to the flu virus (H3N2) during and after infection and how the flu virus is transmitted in the environment. The study will used a flu virus called the H3N2 influenza challenge virus which was produced specifically for use in clinical research in controlled conditions. The study will also assess the safety of the H3N2 influenza challenge in healthy subjects. Mild to moderate symptoms are expected based on previous studies with this strain of influenza.",[29],"2026-03-24",{"date":603,"type":38},"2026-03-27",{"date":605,"type":38},"2022-05-24",{"date":607,"type":23},"2027-12",{"name":394,"class":255},{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":615,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":18,"minAge":549,"maxAge":4,"enrollmentInfo":617,"targetDuration":4,"studyType":24,"phases":619,"briefSummary":620,"conditions":621,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":626,"completionDateStruct":628,"leadSponsor":630,"locationsCount":85},"100630298","phase-3-influenza-vaccination-strategy-for-patients-with-hematologic-malignancy-100630298","NCT07485855","Influenza Vaccination Strategy for Patients With Hematologic Malignancy","Comparison of Immunogenicity of Different Influenza Vaccines in Patients With Hematologic Malignancies","(HEM-FLU)","Inclusion Criteria:\n\n* Adults aged 19 years or older\n* Confirmed diagnosis of hematologic malignancy, including:\n\nnon-Hodgkin lymphoma, Hodgkin lymphoma, acute leukemia, chronic leukemia, or plasma cell disorders\n\nExclusion Criteria:\n\n* Difficulty with repeated venipuncture or blood sampling (e.g., poor vascular access or bleeding tendency)\n* Cognitive or psychiatric impairment precluding understanding of or cooperation with study procedures\n* Known hypersensitivity to influenza vaccine components\n* Influenza vaccination within the preceding 6 months\n* Any other condition deemed clinically inappropriate for study participation at investigator discretion",{"count":618,"type":23},60,[270],"This randomized controlled trial evaluates and compares the immunogenicity of three different influenza vaccine formulations: high-dose trivalent (HD-IIV3), MF59-adjuvanted quadrivalent (aIIV4), and standard-dose trivalent (SD-IIV3) vaccines. The study population consists of patients with hematologic malignancies, including those undergoing autologous stem cell transplantation or CAR-T cell therapy. The primary goal is to identify which vaccine strategy elicits the most robust antibody and T cell-mediated immune responses in this severely immunocompromised population",[622,29,623],"Hematologic Neoplasms","Immunogenicity","2026-03-20",{"date":601,"type":38},{"date":627,"type":38},"2025-12-04",{"date":629,"type":23},"2028-04-30",{"name":631,"class":255},"Asan Medical Center",{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":636,"acronym":4,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":18,"minAge":638,"maxAge":4,"enrollmentInfo":639,"targetDuration":4,"studyType":24,"phases":641,"briefSummary":642,"conditions":643,"keywords":644,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":46},"100611148","phase-3-suraxavir-marboxil-and-oseltamivir-for-influenza-prophylaxis-under-a-hospital-based-setting-100611148","NCT07236814","Suraxavir Marboxil And Oseltamivir for Influenza Prophylaxis Under a Hospital-based Setting","1.Inclusion Criteria:\n\n(1)Inclusion Criteria for Index Cases:\n\n① Patients hospitalized at a participating medical institution.\n\n* The subject and\u002For their legal guardian agrees to participate in this clinical study, has signed the informed consent form, and is able to comply with the protocol requirements for follow-up and complete all study procedures and assessments.\n\n  * Age ≥ 2 years.\n\n    * Positive for influenza virus as determined by a Rapid Antigen Test (RAT) or Nucleic Acid Amplification Test (NAAT) on a respiratory specimen (e.g., oropharyngeal swab, nasopharyngeal swab, sputum, or bronchoalveolar lavage fluid).\n\n      (2) Inclusion Criteria for Room Contacts:\n\n      ① Patients hospitalized at a participating medical institution.\n* The subject and\u002For their legal guardian agrees to participate in this clinical study, has signed the informed consent form, and is able to comply with the protocol requirements for follow-up and complete all study procedures and assessments.\n\n  ③ Age ≥ 12 years.\n  * Expected to remain hospitalized for ≥ 72 hours.\n\n    * Shares a room with at least one hospitalized index case who has been confirmed with influenza virus infection by RAT or NAAT on a respiratory specimen within the last 120 hours and developed influenza-related symptoms within the last 120 hours, and is expected to share the same room for ≥ 24 hours.\n\n      ⑥ Negative for influenza virus as determined by a Nucleic Acid Amplification Test (NAAT) on a throat swab collected on Day 1.\n\n      3.Exclusion Criteria\n\n      (1) Index Cases There are no exclusion criteria for index cases. (2) Exclusion Criteria for Room Contacts:\n      * Room contacts with a known allergy to the active ingredients or excipients of the investigational drugs.\n* Room contacts who have been diagnosed with or have had an influenza virus infection in the past 12 weeks.\n\n  * Use of any anti-influenza antiviral drugs within 2 weeks prior to screening, including: neuraminidase inhibitors, polymerase inhibitors, hemagglutinin inhibitors, and M2 ion channel blockers (e.g., Oseltamivir, Zanamivir, Peramivir, Favipiravir, Arbidol, Baloxavir Marboxil, Amantadine, or Rimantadine, or other anti-influenza drugs approved by the NMPA).\n\n    * Known to be pregnant or breastfeeding. (Subjects who suspect they may be pregnant must report this to the investigator, who will confirm with a pregnancy test).\n\n      * History of fever (axillary temperature ≥ 37.3°C) within 72 hours prior to screening.\n\n        * Child-Pugh class B or C, or an eGFR ≤ 60 mL·min-¹·(1.73 m²)-¹. ⑦ Any subject deemed unsuitable for participation in the study by the investigator.","12 Years",{"count":640,"type":23},384,[270],"This study aims to evaluate the efficacy of antiviral prophylaxis in preventing in-hospital influenza transmission. We will enroll hospitalized patients with confirmed influenza (index cases) and their uninfected roommates (room contacts). These room contacts will be randomized in a 1:1:1 ratio to one of three prophylactic groups: placebo, suraxavir marboxil, or oseltamivir. The primary outcome will be the rate of influenza infection among the room contacts, which will be monitored to determine the effectiveness of the interventions.",[29],[438,645,646],"suraxavir marboxil","oseltamivir","2026-03-19",{"date":514,"type":38},{"date":650,"type":38},"2025-11-28",{"date":652,"type":23},"2027-03-06",{"name":654,"class":255},"Capital Medical University"]