[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"influenza-healthy-volunteers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:influenza-healthy-volunteers":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100619279","evaluating-modes-of-influenza-transmission-2b-baseline-sar-100619279",false,"NCT07342556","Evaluating Modes of Influenza Transmission 2b Baseline SAR","EMIT-2b: Evaluating Modes of Influenza Transmission Through the Conduct of Controlled Human Influenza Virus Infection Transmission Trials (CHIVITTs)","EMIT-2b-1","Inclusion Criteria Recipients:\n\n1. Enrolled in the Recipient Registry (UMD IRB Protocol # 2303473, eligible age ≥18 and ≤49)\n2. Provides written informed consent, can comply with the planned study procedures, is available for an up to \\~14-day home semi-quarantine period, and can attend scheduled exposure events and scheduled follow-up visits.\n3. Participants must be able to comprehend the study requirements, as evidenced by a score of 100% on the comprehension assessment (repeated tries permitted).\n4. No significant change (for the worse) in general health history or in concomitant medication use, as compared from their responses collected during screening (Recipient Protocol).\n5. Live in a private, single occupancy bedroom and agree to take precautions to avoid contracting a respiratory infection outside of the controlled exposure events through a home semi-quarantine prescribed by investigators.\n6. Agree not to meet with other participants (Recipients or Donors) outside of the programmed exposure events during their participation in the home semi-quarantine.\n\nExclusion Criteria Recipients:\n\n1. Female of childbearing potential who has a positive urine pregnancy test within 24 hours of enrollment in a Recipient Cohort or is breastfeeding or planning to become pregnant within 2 months after enrollment.\n2. Presence of infection with influenza, SARS-CoV-2, or other respiratory pathogens detected via a multiplex nucleic acid amplification test (e.g., TaqMan Array Card assay) at entry to the transmission trial.\n\n   a. Volunteers with influenza infection may be eligible to enroll as Donors.\n3. Within the past 72 hours, presence of influenza-like illness, as defined as fever of ≥100.2°F AND cough or sore throat, in the absence of an alternative cause.\n4. Receipt of any blood products within the past 2 months.\n5. Does not agree to provide permission for secondary research use of extra samples collected and stored specimens.\n6. Habitual smoker of tobacco, marijuana, or e-cigarettes per self-report. (Habitual smokers are those who smoke or vape more than four cigarettes, other tobacco products, e-cigarettes or marijuana in a week for more than three months or use an inhaled nicotine or marijuana product more than 3 days a week on average. Edible or patch forms of tobacco or marijuana products do not constitute an exclusion.)\n7. Self-reported or known history of alcohol or drug abuse in the past two years and\u002For illicit drug use within the last 30 days. (Prescribed stimulants for the treatment of ADHD and cannabinoids use do not constitute exclusionary criteria)\n8. Has an ongoing symptomatic condition for which the individual has had or has ongoing medical investigations but has not yet received a diagnosis or treatment plan. (symptomatic condition means for example ongoing chronic fatigue without a diagnosis for symptom.)\n9. Presence of self-reported or medically documented significant medical or psychiatric condition(s) Significant medical or psychiatric conditions include but are not limited to:\n\n   1. Respiratory disease (e.g., chronic obstructive pulmonary disease \\[COPD\\], asthma, cystic fibrosis) requiring daily medications\\* currently or any treatment of respiratory disease exacerbations or hospitalizations for acute respiratory illnesses (e.g., asthma exacerbation) in the last 5 years. (\\* Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long and short acting beta agonists, theophylline, ipratropium, biologics.)\n   2. Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis as an adult.\n   3. Neurological or neurodevelopmental conditions (e.g., epilepsy, stroke, seizures, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis).\n   4. Ongoing malignancy or recent diagnosis of malignancy, including leukemia; treated, non-melanoma skin cancers are permissible.\n   5. An autoimmune disease.\n   6. An immunodeficiency of any cause.\n   7. A blood disorder (e.g., sickle cell disease)\n   8. Endocrine disorders (e.g., diabetes)\n   9. Liver, kidney, metabolic disorders\n   10. BMI ≥40 kg\u002Fm2\n   11. Persistent post-viral syndromes with ongoing cardiovascular, respiratory, or neurologic conditions.\n   12. Any other condition or behavior that in the opinion of the PI would affect the ability to participate in the screening or future transmission studies.\n10. Presence of immunosuppression or any medications that may be associated with impaired immune responsiveness. Including, but not limited to, corticosteroids exceeding 10 mg\u002Fday of prednisone equivalent, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or systemic corticosteroids or other similar or toxic drugs during the preceding 2-month period. Low dose topical and intranasal steroid preparations used for a discrete period are permitted.\n11. Known allergy or intolerance to treatments for influenza and other respiratory infections (including but not limited to oseltamivir, baloxavir, acetaminophen\u002Fparacetamol).\n12. History of a previous severe allergic reaction to medicines of any kind with generalized urticaria, angioedema, or anaphylaxis.\n13. Participating in any other interventional clinical trial that has a scheduled intervention 30 days prior to the start or after the end of the home semi-quarantine.\n\nInclusion Criteria Donors:\n\n1. Provides written informed consent, able to comply with the planned study procedures, available for between 1 and 5 days of multiple hour daily transmission experiments in a controlled environment research facility for the transmission trial and can attend the scheduled follow-up visits.\n2. Comprehends the study requirements, as evidenced by a score of 100% on the comprehension assessment (repeated tries permitted).\n3. Males and non-pregnant, non-breastfeeding females1 aged ≥18 and ≤59 years of age, at time of initial consent. Pregnancy and breastfeeding status to be determined by self-report.\n4. Agrees to the collection of specimens for secondary research.\n5. Evidence of onset of respiratory infection within the past 48 hours at time of entry into the Donor's initial exposure event, including one or more of the following:\n\n   1. Onset of influenza-like illness, as defined as fever (measured oral temperature of ≥100.2°F or self-reported fever in the absence of a measured temperature) AND cough or sore throat in the setting of local influenza activity.\n   2. Onset of less specific symptoms with a positive molecular test for influenza virus infection.\n   3. Laboratory-confirmed influenza infection (including rapid antigen test in the setting of known local influenza activity) with significant exposure to a laboratory confirmed influenza case (e.g., a roommate) within the last 4 days in the absence of symptoms.\n\nExclusion Criteria Donors:\n\n1. Female of childbearing potential who is breastfeeding or has positive urine pregnancy test upon enrollment.\n2. Presence of self-reported or medically documented significant medical or psychiatric condition(s) Significant medical or psychiatric conditions include but are not limited to:\n\n   1. Respiratory disease (e.g., chronic obstructive pulmonary disease \\[COPD\\], asthma, cystic fibrosis) requiring daily medications currently or any treatment of respiratory disease exacerbations or hospitalizations for acute respiratory illnesses (e.g., asthma exacerbation) in the last 5 years. Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long and short acting beta agonists, theophylline, ipratropium, biologics.\n   2. Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis as an adult.\n   3. Neurological or neurodevelopmental conditions (e.g., epilepsy, stroke, seizures, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis).\n   4. Ongoing malignancy or recent diagnosis of malignancy, including leukemia; treated, non-melanoma skin cancers are permissible.\n   5. An autoimmune disease.\n   6. An immunodeficiency of any cause.\n   7. A blood disorder (e.g., sickle cell disease)\n   8. Endocrine disorders (e.g., diabetes)\n   9. Liver, kidney, metabolic disorders\n   10. BMI ≥40 kg\u002Fm2\n   11. Persistent post-viral syndromes with ongoing cardiovascular, respiratory, or neurologic conditions.\n   12. Any other condition or behavior that in the opinion of the PI would affect the ability to participate in the transmission study over the next several days.\n   13. Meets criteria for escalation of care at the time of enrollment visit (will be referred for care).\n3. Presence of immunosuppression or any medications that may be associated with impaired immune responsiveness Including, but not limited to, corticosteroids exceeding 10 mg\u002Fday of prednisone equivalent, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or systemic corticosteroids or other similar or toxic drugs during the preceding 2-month period. Low dose topical and intranasal steroid preparations used for a discrete period are permitted.\n4. Ongoing symptomatic condition for which individual has had or has ongoing medical investigations but has not yet received a diagnosis or treatment plan.\n\n   e.g., ongoing and debilitating fatigue without a diagnosis for the symptom.\n5. Self-reported or known history of alcohol or drug abuse within the past two years or illicit drug use within the last 30 days.\n6. Is a habitual smoker of tobacco, marijuana, or e-cigarettes per self-report. Habitual smokers are those who smoke or vape more than four cigarettes, other tobacco products, e-cigarettes or marijuana in a week for more than three months or use an inhaled nicotine or marijuana product more than 3 days a week on average. Edible or patch forms of tobacco or marijuana products do not constitute an exclusion.\n7. Known allergy or intolerance to treatments for influenza and other respiratory infections (including but not limited to acetaminophen\u002Fparacetamol).\n8. History of a previous severe allergic reaction to medicines of any kind with generalized urticaria, angioedema, or anaphylaxis.\n9. Presence of infection with SARS-CoV-2, as detected via a multiplex nucleic acid amplification test (e.g., Cepheid 4-Plex).\n10. Participating in any other interventional clinical research study that has a scheduled intervention 30 days prior to or after the transmission trial.\n11. Any condition, to include medical and psychiatric conditions, that in the opinion of the Investigator, might interfere with the safety of the participant or the study objectives.",true,"ALL","18 Years","49 Years",{"count":22,"type":23},80,"ESTIMATED","INTERVENTIONAL",[26],"NA","This is a research study to investigate how influenza transmits from person-to-person. Participation as a healthy \"Recipient\" in this study involves:\n\n* Home semi-quarantine lasting about 14 days during which the participants must wear an N95 in class and take other precautions\n* Daily assessments and clinic visits for 14 days\n* Spending every weekday evening for about 14 days from around 6 - 10 pm, including a provided dinner, in a controlled environment. There may be additional sessions and different required participation times on weekends\n* Exposure to people infected with influenza in the controlled environment\n* Three blood draws, at the start, at the end of 14 days, and about a month after the end.\n* A follow-up clinic visits one month after the end of home semi-quarantine\n* A two-month follow-up phone call. This study may increase the participant's risk of catching influenza.\n\nIf the participants get infected during the study, the investigators may:\n\n* Provide the participants with a prescription for antiviral medication or\n* Refer the participants for medical care\n* Ask the participants to become a Donor and expose other Recipients.\n\nThe participants will be compensated for their time and active participation in the study; however, they may not personally benefit from the study. While the participants may receive supportive care for an infection resulting from the study, this is not meant to replace their regular medical care. If the participants become very ill and need referral for medical care, they or their medical insurance will be billed.\n\nIf the participants are someone who recently became infected with influenza either through their daily activities or by participating in this study as a Recipient, they are invited to participate in this research study as a Donor and interact with a group of health participants in a controlled environment. Participation in this study as a Donor involves exposing Recipients for at least one and up to five days including:\n\n* Attend exposure events in a controlled environment\n\n  * Weekday evenings from around 6-10 pm\n  * Additional day and evening events on weekends\n  * Events include a provided dinner\n* Daily assessments and clinic visits for 1 to 5 days\n* Provide exhaled breath samples for 30 to 60 minutes\n* Three blood draws, at the start and end of exposure events, and about a month after the end\n* A follow-up clinic visit one month after their last exposure event\n* A two-month follow-up phone call\n\nIf the participants experience severe symptoms related to their influenza infection, we may:\n\n* Provide the participants with a prescription for antiviral medication or\n* Refer the participants for medical care\n\nThe participants will be compensated for their time and active participation in the study; however, they may not personally benefit from the study. While the participants may receive supportive care for their influenza infection, this is not meant to replace their regular medical care. If the participants become very ill and need referral for medical care, they or their medical insurance will be billed.",[29],"Influenza (Healthy Volunteers)",[31,32,33,34,35],"influenza","airborne transmission","infection transmission","touch transmission","spray (droplet) transmission","NOT_YET_RECRUITING","2026-01-13",{"date":39,"type":40},"2026-01-15","ACTUAL",{"date":42,"type":23},"2026-01",{"date":44,"type":23},"2026-05",{"name":46,"class":47},"University of Maryland, College Park","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":24,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100616407","phase-1-establishing-a-controlled-human-infection-model-for-influenza-h3n2-as-a-foundation-for-pandemic-preparedness-100616407","NCT07305207","Establishing a Controlled Human Infection Model for Influenza H3N2 as a Foundation for Pandemic Preparedness","A Double-blinded, Phase 1 Clinical Trial to Establish an RG-A\u002FTexas\u002F71\u002F2017 (H3N2) Influenza Controlled Human Infection Model (CHIM) That Safely and Reproducibly Induces Symptomatic Influenza Virus Infection in Healthy Adults 18-45 Years of Age After Intranasal Challenge","Inclusion Criteria:\n\n1. Written informed consent obtained from the participant.\n2. 18-45 years of age.\n3. Good general health status, as determined by history and physical examination conducted no longer than 30 days prior to the challenge date.\n4. HAI antibody titer ≤1:40 against influenza A\u002FTexas\u002F71\u002F2017 (H3N2).\n5. Eligibility laboratory values\\* (complete blood cell count with differential (CBC-D), biochemistry (creatinine (Cr), total bilirubin, blood urea nitrogen (BUN), aspartame aminotransferase (AST), alanine transaminase (ALT), and c-reactive protein (CRP))\\*Labs within normal range or grade 1 abnormalities deemed not clinically significant by a study investigator are considered acceptable.\n6. Vital signs\\*\\* as follows:\n\n   1. Pulse is 47 to 99 beats per minute\n   2. Systolic blood pressure is 85 to 139 mmHg\n   3. Diastolic blood pressure is 55 to 89 mmHg\n   4. SpO2 ≥ 95%; RR ≤ 18\n   5. Oral temperature is less than 38.1°C \\*\\*Clinical judgement when characterizing vital signs will be used in the context of certain populations according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (e.g. conditioned athletes, white coat hypertension etc.)\n7. If a person is at risk of becoming pregnant, has practiced adequate contraception for 28 days prior to challenge, and has a negative pregnancy test on the screening day and the day before influenza A\u002FH3N2 challenge (Check-in Day) and has agreed to continue adequate contraception until 60 days after challenge.\n\n   Risk of pregnancy is defined as any individual assigned female at birth or with reproductive capacity who is sexually active with individuals with sperm-producing capabilities. Individuals who have received the following are considered to not have reproductive capacity:\n   * Documented hysterectomy\n   * Documented bilateral salpingectomy\n   * Documented bilateral oophorectomy\n   * Documented and current bilateral tubal ligation or occlusion\n   * Credible self-reported history of diagnosed infertility\n   * Hormone therapy (e.g. testosterone), provided it is administered consistently and medically assessed as sufficient to reduce pregnancy such that ovulation has ceased\n   * Any other condition, as determined by the Principal Investigator\u002Fstudy physician, that would render an individual incapable of becoming pregnant\n\n   Adequate contraception is defined as a contraceptive method with a failure rate of \\\u003C1% per year when used consistently and correctly and, when applicable, in accordance with the product label. Examples include the following:\n   * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal\n   * Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable CI2403.03November2025\\_V3.0 52\n   * Intra-uterine device (IUD) with or without hormonal release\n   * Vasectomized partner, if this is the participant's sole partner and the partner has received a medical assessment of the surgical success\n   * Credible (as deemed by the Investigator\u002Fstudy physician) self-reported history of abstinence for at least 28 days prior to challenge\n8. Participants who, in the opinion of the Investigator\u002Fstudy physician, can and will comply with the requirements of the protocol (e.g., inpatient stay, complete eDiary Cards, return for follow-up visits).\n\nExclusion Criteria:\n\n1. Underlying chronic medical condition requiring ongoing follow-up and monitoring by a physician (e.g., diabetes, seizure disorder).\n2. Underlying renal disease or disorders requiring ongoing follow-up and monitoring by a physician. In the event a participant has a minimally elevated BUN and\u002For Cr at screening, the participant will either be excluded or an eCRF or creatinine clearance may be conducted to determine eligibility.\n3. Underlying coagulation disorder history. In the event a participant reports a personal history of undiagnosed prolonged bleeding and\u002For recurrent nosebleeds or a personal or family history of coagulation disorders, a bleeding panel (PTT, INR, fibrinogen) will be used to rule out coagulopathy.\n4. Underlying cardiac conditions including:\n\n   1. Hypertension, angina, or prior myocardial infarction\n   2. Structural or functional cardiac disease (e.g., dilated cardiomyopathy, congestive heart failure)\n   3. With a history of arrhythmias\u002Fdysrhythmias (e.g., torsades de pointes, atrial fibrillation)\n   4. Cardiac conduction abnormalities (e.g., congenital or acquired heart block)\n   5. Uncorrected or ongoing serum electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia)\n5. Underlying pulmonary disease including asthma, emphysema, chronic bronchitis, pulmonary tuberculosis or any other structural or functional pulmonary condition (e.g., history of severe airway hyper-responsiveness).\n6. FEV1\u002FFEV6 \\\u003C 0.73 as an indication of potential airflow limitation.\n7. Known allergy to excipients in the challenge virus inoculum and placebo. The excipient (diluent and placebo) is SPG: sucrose, KH2PO4, K2HPO4, L-glutamic acid.\n8. Moderate or severe symptoms of health anxiety, anxiety, and mood symptoms. Self-reported current diagnosis of a major psychiatric illness, including, but not limited to, a schizophrenia spectrum disorder, bipolar disorder, posttraumatic stress disorder, obsessive compulsive disorder, substance use disorder, or eating disorder, based on standardized mental health screening tools.\n9. Habitual\\*\\*\\* smoker of tobacco, e-cigarettes or marijuana. \\*\\*\\*Habitual smokers are those who smoke more than four cigarettes, other tobacco products, e-cigarettes (to include vaping and Juuling products) or marijuana in a week and cannot agree to abstain from smoking cigarettes, other tobacco products, e-cigarettes and\u002For marijuana products during participation in the study.\n10. Any current daily use of illicit drugs whereby the individual and\u002For study staff assess that the individual cannot abstain from during the isolation period.\n11. Any current daily alcohol consumption whereby the individual and\u002For study staff assess that the individual cannot abstain during the isolation period.\n12. History of allergic rhinitis and\u002For any condition that causes similar symptoms, including chronic cough.\n13. Pregnant (known before or established at the time of screening using a urine pregnancy test) or breastfeeding.\n14. Immunocompromised (with HIV\u002FAIDS or receiving immunosuppressive therapy involving steroids) or any medical condition or medication that leads to a compromised immune system.\n15. Screening blood work positive for HBV, HCV, or HIV.\n16. Influenza virus detected in NPS sample prior to challenge using RT-qPCR and\u002For culture isolation, or detection of other respiratory infection.\n17. Received influenza vaccination within the last 4 months prior to screening based on history described by participant or planned receipt up to Study Day 57.\n18. Living with, working with, or in close contact with children less than 6 months of age, or a household member(s) highly recommended to receive an annual influenza vaccination by NACI\\*\\*\\*\\* and that have not been immunized with influenza vaccine within the last year or immunized less than 3 weeks prior to challenge.\n\n    \\*\\*\\*\\*Individuals that are highly recommended by NACI to receive an influenza vaccine and potentially at risk include the following (52): (52):\n    1. All children 6-59 months of age\n    2. Adults and children with the following chronic health conditions:\n\n    i. Cardiac or pulmonary disorders (including bronchopulmonary dysplasia, cystic fibrosis and asthma) ii. Diabetes mellitus and other metabolic diseases iii. Cancer, immune compromising conditions (due to underlying disease, therapy, or both, such as solid organ transplant or hematopoietic stem cell transplant recipients) iv. Renal disease v. Anemia or hemoglobinopathy vi. Neurologic or neurodevelopmental conditions (includes neuromuscular, neurovascular, neurodegenerative, neurodevelopmental conditions and seizure disorders \\[and, for children, includes febrile seizures and isolated developmental delay\\], but excludes migraines and psychiatric conditions without neurological conditions) vii. Morbid obesity (defined as Body Mass Index (BMI) ≥ 40 kg\u002Fm2) viii. Children six months to 18 years of age undergoing treatment for long periods with acetylsalicylic acid, because of the potential increase of Reye syndrome associated with influenza c. All individuals who are pregnant d. All individuals of any age who are residents of nursing homes and other chronic care facilities e. Adults 65 years of age and older f. Indigenous Peoples\n19. Any contraindication to receiving oseltamivir or zanamivir including known history of negative\u002Fanaphylactic reactions. Inability to take capsules containing gelatin or sorbitol (oseltamivir) or lactose-intolerant (zanamivir)\n20. Recent (within the 6 months before Screening Day) nasal or sinus surgery or diagnosis with nasal polyps.\n21. Recent use (4 weeks of Screening Day) of intranasal steroids, antihistamines, or any substance (including legally prohibited or prescription drug) that is administered nasally.\n22. Receipt of any investigational drug or vaccine within 6 months prior to challenge. An investigational drug or vaccine is one that is still being tested in clinical trials that has not yet been authorized for use in Canada for administration by public programs.\n23. Receipt of any authorized vaccines within 2 weeks prior to being challenged.\n24. Previous moderate or severe laboratory-confirmed SARS-CoV-2\u002FCOVID-19, influenza infection, or any other respiratory virus infection (e.g., RSV) that required hospitalization.\n25. Head trauma (e.g., fracture of the cribriform plate) within 1 year of screening.\n26. Symptoms indicative of acute respiratory illness (such as fever, cough, difficulty breathing) identified during the physical examination done on Study Day -1 (check-in) or Day 1 before a participant is challenged. In the event a participant reports changes to their medical history since screening up until check-in, a history-directed respiratory panel will be administered and any positive respiratory virus including SARS-COV-2 will be exclusionary\n27. History of Bell's Palsy, Guillain-Barre, and\u002For facial paralysis.\n28. Receipt of facial cosmetic filler, or any facial neuromodulator, in the past 3 months.\n29. Self-reported sleep apnea that requires a continuous positive airway pressure (cPap) machine\n30. Receipt of blood or blood products during the six months prior to the planned date of challenge.\n31. Plans to donate blood anytime throughout the study.\n32. Any other finding that the Investigator\u002Fstudy physician considers will make the participant unsuitable for the study or unable to comply with the study requirements.","45 Years",{"count":58,"type":23},32,[60],"PHASE1","The overall objective is to establish an influenza Controlled Human Infection Model (CHIM) in Canada that can be used to assess the safety and efficacy of candidate vaccines, biologics, and therapeutics targeting influenza viruses.",[29],[64,65,66,67,68,69],"human challenge","Controlled human infection model","Influenza","intranasal challenge","Phase 1 clinical trial","Immune response","2025-12-12",{"date":72,"type":40},"2025-12-26",{"date":74,"type":23},"2026-02-01",{"date":76,"type":23},"2028-01-31",{"name":78,"class":47},"Dalhousie University",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":17,"sex":18,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":99,"locationsCount":48},"100569421","post-marketing-surveillance-study-for-the-safety-of-efluelda-tetra-pre-filled-syringe-100569421","NCT06694025","Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe.","Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe, a High-dose Quadrivalent Influenza Vaccine Administered to Adults 65 Years or Older in the Republic of Korea.","Inclusion Criteria:\n\n* Adults aged 65 years or older on the day of enrollment\n* The informed consent form has been signed and dated\n* Receipt of 1 dose of Efluelda Tetra on the day of enrollment according to the approved local product label\n\nExclusion Criteria:\n\n* Previous history of enrollment in this study\n* Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device or medical procedure","65 Years",{"count":88,"type":23},670,"OBSERVATIONAL","To investigate the incidence of adverse events (AEs) and adverse drug reactions (ADRs) occurred following administration of Efluelda Tetra in adults aged 65 years or older under routine clinical practice, as per approved indications.\n\nThe study duration of each participation will be approximately 28 to 35 days. In the event that Visit 2 is not made, the study duration would be extended to 36 to 42 days.",[92,29],"Immunization","2025-12-05",{"date":95,"type":40},"2025-12-15",{"date":97,"type":23},"2026-10-01",{"date":76,"type":23},{"name":100,"class":101},"Sanofi","INDUSTRY"]