[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"respiratory-syncytial-virus-rsv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:respiratory-syncytial-virus-rsv":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,39,64,89,110,142,173,198,220,247,281,310,406,428,449,477,507,533,558],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":24,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100644801","real-world-effectiveness-of-rsv-vaccines-among-adults-using-target-trial-emulation-in-epic-cosmos-100644801",false,"NCT07673081","Real-World Effectiveness of RSV Vaccines Among Adults Using Target Trial Emulation in Epic Cosmos","Inclusion: Vaccinated Cohort\n\nPatients must meet all the following inclusion criteria to be eligible for inclusion in the vaccinated cohort:\n\nAdults meet the age criteria at the index date. Non-pregnant at the index date. Have at least one clinical encounter recorded in Epic Cosmos database during the 12 months prior to the index date.\n\nHave a documented administration of ABRYSVO® (or AREXVY®，mRESVIA® in the later phase) in Epic Cosmos on or after August 2023.\n\nThe index date for vaccinated individuals will be defined as the date of RSV vaccination.\n\nUnvaccinated Cohort\n\nPatients must meet all the following inclusion criteria to be eligible for inclusion in the unvaccinated cohort:\n\nAdults meet the age criteria at the index date. Non-pregnant at the index date. Have at least one clinical encounter recorded in Epic Cosmos database during the 12 months prior to the index date.\n\nHave no documented receipt of any RSV vaccine in Epic Cosmos on or prior to the trial start date.\n\nThe index date for unvaccinated individuals will be defined as the start date of each sequential trial (e.g., 1st date of each month) in which they met eligibility criteria.\n\nExclusion:\n\nVaccinated Cohort\n\nPatients meeting any of the following criteria will not be included in the vaccinated cohort:\n\nIndividual with receipt of any RSV vaccine in Epic Cosmos prior to the trial start date, as defined above (applicable to all analyses except for the analysis of recipients of multiple doses).\n\nNon-US residents. Unvaccinated Cohort\n\nPatients meeting any of the following criteria will not be included in the unvaccinated cohort:\n\nIndividual with receipt of any RSV vaccine in Epic Cosmos on or prior to the trial start date, as defined above.\n\nNon-US residents. Patients must meet all the inclusion criteria and none of the exclusion criteria to meet eligibility requirements.","ALL","18 Years",{"count":18,"type":19},293334,"ESTIMATED","OBSERVATIONAL","Among non-pregnant adults observed in Epic Cosmos since August 2023 who are eligible for RSV vaccination, what is the effectiveness of ABRYSVO® (RSVpreF), compared with unvaccinated individuals, in preventing RSV-related and all-cause acute respiratory illness (ARI), lower respiratory tract disease (LRTD), and other outcomes of interest, within a target trial emulation (TTE) framework",[23],"Respiratory Syncytial Virus (RSV)",[25,26],"RSV, Respiratory Syncytial Virus","Vaccine effectivness","NOT_YET_RECRUITING","2026-06-22",{"date":30,"type":31},"2026-06-29","ACTUAL",{"date":33,"type":19},"2026-06-20",{"date":35,"type":19},"2026-11-30",{"name":37,"class":38},"Pfizer","INDUSTRY",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100641496","phase-3-a-phase-3-study-in-india-to-describe-the-safety-and-immunogenicity-of-rsvpref-100641496","NCT07653100","A Phase 3 Study in India to Describe the Safety and Immunogenicity of RSVpreF","A PHASE 3 STUDY IN INDIA TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS","Key Inclusion Criteria:\n\n* Participants ≥18 years of age at Visit 1.\n* Participants who are ambulatory and live independently in the community.\n* Participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.\n* Applicable to participants 18 through 59 years of age: Participants who are healthy or have stable preexisting diseases. These participants are considered at high risk of RSV disease by having at least 1 reportable stable chronic medical condition(s) that belongs to 1 or more of the following:\n* Chronic heart disease (ie, coronary artery disease, heart failure, or congenital heart disease)\n* Chronic lung disease (ie, COPD, emphysema, asthma, interstitial lung disease, or cystic fibrosis)\n* Nongestational diabetes mellitus type 1 or type 2\n* Severe obesity (body mass index \\[BMI\\] ≥40 kg\u002Fm2)\n* Chronic liver disease (ie, cirrhosis)\n* Chronic kidney disease (not including end-stage renal disease with or without dialysis)\n* Chronic neurological disease that causes impaired airway clearance or respiratory muscle weakness (ie, poststroke dysphagia, amyotrophic lateral sclerosis, or muscular dystrophy)\n* Chronic hematologic disease (ie, sickle cell disease or thalassemia)\n\nNote: A chronic medical condition for this study is defined as:\n\n* Duration ≥6 months.\n* Requires regular medical follow-up or ongoing prescribed medication or hospitalization in the previous year.\n* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in the protocol.\n\nKey Exclusion Criteria:\n\n* Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.\n* History of severe adverse reaction associated with a vaccine and\u002For severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.\n* Prior history of any subtype of Guillain-Barré syndrome of any etiology.\n* Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.\n* Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and\u002For laboratory\u002Fphysical examination.\n* Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, immunosuppressive monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study.",true,{"count":48,"type":19},540,"INTERVENTIONAL",[51],"PHASE3","The purpose of this phase 3 multicenter, double-blinded, placebo-controlled study in India is to learn about the safety and immunogenicity of RSVpreF in adults.",[23],[55],"RSV, Vaccine","2026-06-11",{"date":58,"type":31},"2026-06-17",{"date":28,"type":19},{"date":61,"type":19},"2027-01-25",{"name":37,"class":38},5,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":49,"phases":74,"briefSummary":75,"conditions":76,"keywords":77,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":63},"100634722","phase-3-a-study-to-learn-safety-and-immune-response-to-study-vaccine--rsvpref-in-adults-at-high-risk-of-severe-rsv-disease-100634722","NCT07543380","A Study to Learn Safety and Immune Response to Study Vaccine -RSVpreF in Adults at High Risk of Severe RSV Disease.","A PHASE 3, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS CONSIDERED AT HIGH RISK OF SEVERE RSV DISEASE IN JAPAN","Key Inclusion Criteria:\n\n• Underlying health condition(s) that can put the participant at an increased risk of severe RSV\u002Fcomplications including chronic lung , heart, kidney, liver, nervous system, blood, or metabolic diseases\n\nKey Exclusion Criteria:\n\n* Received any kind of RSV vaccine before participating in this study\n* Determined as not eligible by the investigator based on the participant's past and present health condition(s), medication(s) and treatment(s)\n\nPlease refer to the study contact for further eligibility details.","59 Years",{"count":73,"type":19},130,[51],"The purpose of the study is to learn about the immune response after a RSVpreF vaccination. This study is being conducted in Japan. RSV is a common virus that can cause infections of the lungs and airways.\n\nThe study is seeking participants who are:\n\n* 18 to 59 years of age\n* adults with health condition(s) that can put them at an increased risk of severe RSV disease\n\nIt will also learn about the safety of RSVpreF vaccination. The study lasts about 2 months. Adults need to visit the research site at least 2 times. The participant will receive a phone call 2 months after vaccination for health checks.",[23],[78,79],"RESPIRATORY SYNCYTIAL VIRUS (RSV)","ADULTS AT HIGH RISK","RECRUITING","2026-05-28",{"date":83,"type":31},"2026-06-02",{"date":85,"type":31},"2026-05-11",{"date":87,"type":19},"2026-08-31",{"name":37,"class":38},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":46,"sex":15,"minAge":95,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":49,"phases":98,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":106,"leadSponsor":108,"locationsCount":4},"100638062","a-study-to-evaluate-the-immune-response-features-following-vaccination-with-a-recombinant-respiratory-syncytial-virus-vaccine-cho-cells-100638062","NCT07618325","A Study to Evaluate the Immune Response Features Following Vaccination With a Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)","Inclusion Criteria:\n\n* Participants must be 20 years of age or older as determined by the investigator at enrollment.\n* Participants must be able to understand study procedures, risks, and benefits, provide voluntary agreement to participate in the study, and sign the informed consent form (ICF).\n* Participants must be willing and able to attend all scheduled follow-up visits and comply with all requirements specified in the study protocol.\n* Females of childbearing potential must use highly effective contraception from 1 month prior to vaccination through 12 months following vaccination.\n\n  * Effective contraceptive methods include: oral contraceptives (excluding emergency contraceptives), contraceptive injections, subcutaneous implants, hormonal patches, intrauterine devices (IUDs), surgical sterilization, true abstinence, and condom use.\n  * Methods not considered effective include: rhythm method, withdrawal method, and emergency contraception.\n\nExclusion Criteria:\n\n\\*Participants who meet any of the following criteria shall be ineligible for enrollment:\n\n* Axillary body temperature ≥ 37.3 °C.\n* History of respiratory syncytial virus (RSV) infection within 6 months prior to enrollment.\n* New-onset respiratory infection symptoms within 7 days prior to enrollment, including cough, expectoration, dyspnea, wheezing, fever, rhinorrhea, and nasal obstruction.\n* Presence of an acute illness or acute exacerbation of a chronic condition within 3 days prior to enrollment.\n* Use of antipyretics and analgesics (excluding enteric-coated aspirin for the prevention of cardiovascular and cerebrovascular diseases) or antiallergic medications within 3 days prior to enrollment.\n* Known hypersensitivity to any ingredient of the study vaccine, including Quillaja saponaria (QS-21), 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC), cholesterol, sucrose, sodium dihydrogen phosphate, anhydrous disodium hydrogen phosphate, polysorbate 80, sodium chloride, hydrochloric acid, and sodium hydroxide; history of severe allergic reactions or serious adverse events following any vaccination or drug administration, including anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local Arthus reaction, and severe urticaria.\n* Pregnant female (positive urine pregnancy test), lactating female, or female with a pregnancy plan within 12 months following vaccination.\n* Congenital asplenia, functional asplenia, or splenectomy due to any cause.\n* Previous or current malignant neoplasm, with the exception of clinically cured carcinoma in situ and papillary thyroid carcinoma.\n* Confirmed diagnosis of an autoimmune disease, including systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, and autoimmune thyroid disease.\n* Confirmed or suspected immunosuppression or immunodeficiency resulting from any cause, including primary or secondary immunocompromise, congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, or treatment with immunosuppressive or cytotoxic agents (e.g., chemotherapy, organ transplantation, or therapy for autoimmune diseases).\n* Any condition that, in the investigator's judgment, would render intramuscular injection unsafe, such as a history of thrombocytopenia or other coagulation disorders.\n* Previous or current serious clinical illness that is not cured (such as serious cardiovascular and cerebrovascular diseases, liver and kidney diseases, respiratory diseases, diabetes with complications, major surgery, etc.) may affect the evaluation of the trial.\n* Previous or current thrombotic diseases.\n* History of untreated tuberculosis or active tuberculosis infection at enrollment.\n* Uncontrolled hypertension defined as systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg on measurement prior to vaccination.\n* History of severe cardiac arrhythmia (e.g., atrial fibrillation).\n* History or family history of convulsions, epilepsy, congenital brain malformation, psychiatric disorders, or other severe neurological conditions associated with cerebral nerve tissue injury, including brain tumor, cerebral hemorrhage, cerebral infarction (excluding lacunar cerebral infarction and cerebral infarction without sequelae), central nervous system infection, and chemical intoxication.\n* History of any cognitive disorder or any moderate or severe condition causing cognitive impairment.\n* Use of any investigational or unlicensed product (medicinal product, vaccine, or medical device) other than the study vaccine within 30 days prior to vaccination, or planned participation in another clinical trial during the study period.\n* Administration of any inactivated vaccine within 14 days prior to vaccination, or any live vaccine within 28 days prior to vaccination.\n* Prior receipt of any RSV vaccine.\n* Administration of immunoglobulin and\u002For any blood or plasma derivative (e.g., gamma globulin, intravenous immunoglobulin) within 3 months prior to vaccination, or planned administration during the study period.\n* Long-term use (consecutive use \\> 14 days) of immunosuppressive or other immunomodulatory agents within 3 months prior to vaccination or planned use during the study period. Systemic glucocorticoids ≥ 20 mg prednisone or equivalent daily for ≥ 14 days are considered long-term use. Topical preparations (ointments, eye drops, inhalations, nasal sprays) at doses not exceeding those recommended in the package insert are permitted.\n* Use of long-acting immunomodulatory agents (e.g., infliximab) within 6 months prior to vaccination or planned use during the study period.\n* History of chronic alcohol abuse and\u002For drug abuse that, in the investigator's judgment, may interfere with study assessments.\n* Planned migration during the study period that would preclude completion of all study procedures.\n* Any other condition that, in the investigator's judgment, may interfere with the validity of study evaluations, with special attention to respiratory infection symptoms.","20 Years",{"count":97,"type":19},60,[99],"NA","The purpose of this study is to elucidate the molecular mechanism by which novel adjuvants enhance the immunogenicity of Respiratory Syncytial Virus (RSV) vaccines by regulating antigen-specific B cell affinity maturation and T cell memory formation.",[23],"2026-05-25",{"date":104,"type":31},"2026-06-01",{"date":83,"type":19},{"date":107,"type":19},"2028-08-31",{"name":109,"class":38},"MAXVAX Biotechnology Limited Liability Company",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":46,"sex":15,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":49,"phases":122,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":141},"100641007","phase-4-thrive---trial-of-passive-humoral-rsv-immunity-for-value-and-effectiveness-100641007","NCT07578298","THRIVE - Trial of Passive Humoral RSV Immunity for Value and Effectiveness","Passive Immunisation With RSV-specific Monoclonal Antibody (RSV-SMA) to Prevent RSV Respiratory Infections Among Aboriginal and Torres Strait Islander Children in the Northern Territory: a Pragmatic Randomised Controlled Trial.","THRIVE","Inclusion Criteria:\n\n1. Aboriginal and\u002For Torres Strait Islander infant ≥ 6 calendar months old and \\\u003C 9 calendar months old.\n2. Parent\u002Fcaregiver is willing for their infant to participate in the study and informed consent for the infant's participation in the study has been given.\n3. Parent\u002Fcaregiver is willing to comply with all study procedures outlined in the protocol, including review of maternal\u002F infant immunisation records, electronic medical records and public health notifications, for the duration of the study.\n\nExclusion Criteria:\n\n1. Infants with a contra-indication to RSV-SMA per the Australian Immunisation Handbook (i.e. anaphylaxis to a prior dose).\n2. Infants who have received a prior dose of RSV-SMA at ≥ 3 calendar months old.\n3. Previously enrolled in this trial.\n\nTemporary Exclusion Criteria\n\n1. Infants who have received a prior dose of RSV-SMA between ≥ 1 calendar months old and \\\u003C 3 calendar months old will be excluded until at least 150 days have passed since their most recent dose. Randomisation can be delayed until participants meet this criterion.\n2. Acute illness at the time of assessment (e.g. fever ≥ 38.5°C, acute respiratory or other infection as determined by trained and delegated study staff) is temporarily excluded until they are recovered and\u002For symptom-free for ≥ 24 hours.","6 Months","9 Months",{"count":121,"type":19},1000,[123],"PHASE4","RSV is a leading cause of severe respiratory illness and hospitalisation for young children, with particularly high rates of RSV respiratory infection observed amongst Aboriginal and Torres Strait Islander children living in Australia's Northern Territory. The goal of this clinical trial is to evaluate whether routinely administering a single dose of respiratory syncytial virus (RSV)-specific monoclonal antibody, nirsevimab, from 6 months old, provides protection against RSV infections for Aboriginal and Torres Strait Islander children throughout in the first and second year of life.\n\nIn this study, participants will be randomly assigned to receive either a single dose of intra-muscular RSV-specific monoclonal antibody, nirsevimab, or standard care (no RSV-specific monoclonal antibody). The primary objective is to determine whether administration ofRSV-specific monoclonal antibody, nirsevimab reduces the occurrence of RSV infection over the subsequent 12 months. Secondary objectives include assessing whether nirsevimab reduces RSV-related hospital attendances, as well as respiratory and all-cause hospitalisations, over the following 6 and 12 months. An assessment of cost-effectiveness will also be undertaken.\n\nParticipants will receive the study intervention at 6 months of age (+90 days). Follow-up will be conducted through passive surveillance using electronic medical records and public health notification systems to capture relevant health outcomes.",[23,126],"Respiratory Infection Virus",[23,128,129,130,131],"bayesian adaptive","pragmatic clinical trial","Aboriginal and Torres Strait Islander","infants","2026-05-05",{"date":85,"type":31},{"date":135,"type":19},"2026-05-15",{"date":137,"type":19},"2030-12-31",{"name":139,"class":140},"Menzies School of Health Research","OTHER",1,{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":46,"sex":15,"minAge":16,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":49,"phases":152,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":172},"100632648","phase-1-study-of-different-formulations-of-vaccines-encoding-the-rsv-monovalent-antigen-or-the-flu-h5-antigen-in-participants-18-to-49-years-of-age-100632648","NCT07516418","Study of Different Formulations of Vaccines Encoding the RSV Monovalent Antigen or the Flu H5 Antigen in Participants 18 to 49 Years of Age","A Phase 1, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Different Formulations of Vaccines Encoding the RSV Monovalent Antigen or the Flu H5 Antigen in Healthy Participants 18 to 49 Years of Age","Inclusion Criteria:\n\n* Aged 18 to 49 years on the day of inclusion\n* A female participant is eligible to participate if she is not pregnant or breastfeeding and of the following conditions applies:\n* Is of NCBP (Non-Child-Bearing Potential). To be considered of NCBP, a female must be post-menopausal for at least 1 year, or surgically sterile. OR\n* Is of CBP (Child-Bearing Potential) and uses an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after the last study intervention administration.\n\nExclusion Criteria:\n\n• Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","49 Years",{"count":151,"type":19},570,[153],"PHASE1","The purpose of this study is to evaluate the safety and immunogenicity of different formulations of vaccines encoding the RSV monovalent antigen or the Flu hemagglutinin subtype 5 (H5) antigen in healthy participants aged 18 to 49 years.\n\nThe total duration of study participation for each participant varies by stage and treatment arm.\n\nStage 1:\n\n* For Arm 1, Arm 2, and Arm 3 the duration of study participation will be approximately 7 months for each participant.\n* For Arm 4, Arm 5, and Arm 6 the duration of study participation will be approximately 6 months for each participant.\n\nStage 2: For all arms, the duration of study participation will be approximately 7 months for each participant.",[23,156],"Influenza A(H5N1)",[158,159,160,161,162,163],"RSV","RSV Infection","RSV Vaccine","Flu","Flu Infection","Flu Vaccine",{"date":165,"type":31},"2026-05-08",{"date":167,"type":31},"2026-04-15",{"date":169,"type":19},"2027-04-04",{"name":171,"class":38},"Sanofi",6,{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":49,"phases":183,"briefSummary":184,"conditions":185,"keywords":186,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":197},"100581553","study-of-palivizumab-in-children-with-high-risk-of-severe-respiratory-syncytial-virus-rsv-disease-100581553","NCT06851806","Study of Palivizumab in Children With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease","A Multicentre, Interventional, Phase IV, Open-label, Study to Evaluate the Safety of Palivizumab in Children Less Than 24 Months of Age With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease","Synagis","Inclusion Criteria:\n\n1. Participants at risk of severe RSV disease defined as fulfilling at least one of the following:\n\n   1. Infants born ≤ 35 wGA and are \\\u003C 6 months of age at enrolment.\n   2. Children \\\u003C 24 months of age at enrolment and requiring treatment for BPD within the last 6 months.\n   3. Children \\\u003C 24 months of age and with haemodynamically significant CHD.\n2. Written informed consent obtained from the participant's parent(s)\u002Flegal guardian and the participant's parent(s)\u002Flegal guardian is able to understand and comply with the requirements of the protocol including follow-up visits as judged by the investigator.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Hospitalisation at the time of enrolment, unless the discharge is expected within 30 days of the time of enrolment\n2. Required mechanical ventilation (including continuous positive airway pressure) or other mechanical respiratory or cardiac support at the time of enrolment.\n3. Anticipated cardiac surgery within 2 weeks after enrolment.\n4. Anticipated survival of \\\u003C 6 months after enrolment in the trial.\n5. Active LRTD, including RSV infection at the time of enrolment and\u002For study intervention administration.\n6. Any fever (≥ 38.0°C) or acute illness within 7 days prior to investigational product administration.\n7. Known history of evolving or unstable neurologic disorder.\n8. Known history of unstable cardiac or respiratory status, including cardiac defects so severe that survival is not expected or for which cardiac transplantation is planned or anticipated.\n9. Known allergy, including to immunoglobulin products, or history of allergic reaction.\n10. Receipt of palivizumab or other RSV monoclonal antibodies or any RSV vaccine, including maternal RSV vaccination.\n11. Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, intravenous immunoglobulin) or anticipated use during the study.\n12. Concurrent enrolment in another interventional study.\n13. Children of employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.\n14. Judgment by the investigator that the participant should not participate in the study if the participant or the participant's parent\u002Flegal guardian is unlikely to comply with study procedures, restrictions, and requirements.",{"count":182,"type":19},138,[99],"This is a Phase IV, prospective, open-label, multicentre study to evaluate the safety of palivizumab IM injection for the prevention of severe LRTD in Indian infants and children who are at high-risk of RSV disease. All enrolled participants will receive palivizumab 15 mg\u002Fkg IM injection once a month for up to 5 injections during the study. Children who undergo cardiac surgery with cardiopulmonary bypass during the study should receive an additional dose of study intervention immediately after surgery, when medically stable for IM injection as determined by the physician. Prior to each study intervention administration, all participants will undergo safety assessments. A follow-up visit will be performed telephonically with the parent(s) or legal guardian(s) of all participants 30 days after their last injection of palivizumab.",[23],[187],"Phase IV","2026-04-16",{"date":190,"type":31},"2026-04-17",{"date":192,"type":31},"2025-12-10",{"date":194,"type":19},"2027-02-28",{"name":196,"class":38},"AstraZeneca",2,{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":46,"sex":206,"minAge":16,"maxAge":149,"enrollmentInfo":207,"targetDuration":4,"studyType":49,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":197},"100630825","phase-1-safety-tolerability-and-immunogenicity-of-a-maternal-respiratory-syncytial-virus-rsv-vaccine-mkk900-in-healthy-adult-women-100630825","NCT07492706","Safety, Tolerability and Immunogenicity of a Maternal Respiratory Syncytial Virus (RSV) Vaccine (MKK900) in Healthy Adult Women","A Phase 1, Randomized, Blinded, Active Controlled Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of a Recombinant, Stabilized Pre-F Respiratory Syncytial Virus (RSV) Vaccine (MKK900), Non-adjuvanted, in Healthy Women Aged 18-49 Years","RSVVaccine","Inclusion Criteria:\n\n1. Adult females 18-49 years old on the day of vaccination.\n2. Generally healthy, as established by medical history and clinical examination before vaccination and absence of unresolved acute disease or acute exacerbation of chronic disease.\n3. Intent to reside in the area of the study site for the throughout the study visits and also available for phone follow ups after vaccination.\n4. Signing an Informed Consent Form indicating that the purpose, procedures and potential risks and benefits of the study have been explained including an opportunity to ask questions.\n5. Females must not be of childbearing potential OR those who are of childbearing potential must be non-pregnant and non-lactating and willing to use acceptable, highly effective methods of contraception from 28 days prior to vaccination on Day -1 through to 90 days after vaccination. Females must also agree not to donate ova from the first dose of the study vaccine until at least 90 days after vaccination.\n\nExclusion Criteria:\n\n1. Recent RSV exposure\u002Fvaccination: History of RSV infection within 6 months or prior RSV vaccination.\n2. Pregnancy\u002Flactation: Pregnant, breastfeeding, or planning pregnancy within 90 days post-vaccination.\n3. Recent investigational products: Received any investigational product within 30 days or plans study participation during this trial.\n4. Recent vaccines: Live vaccine within 30 days or any other vaccine within 14 days before study vaccination, or planned vaccination within 3 months after.\n5. Blood products: Received immunoglobulins or blood products within 6 months.\n6. Recent blood donation: Donation\u002Floss of \\>450 mL of blood or components within 14 days of Day 1.\n7. Active illness: Acute illness or acute flare of chronic disease within 3 days before vaccination.\n8. Vaccine allergies: Allergy to vaccine components (especially aminoglycosides) or severe reactions to past vaccines.\n9. Neurological conditions: History of seizures, epilepsy, encephalopathy, or significant neurological disorders.\n10. Mental health concerns: Any mental illness that may affect study compliance or AE reporting.\n11. Malignancy: Active cancer or cancer within past 5 years (except adequately treated skin or cervical lesions).\n12. Splenic issues: Asplenia, functional asplenia, or splenectomy.\n13. Immunodeficiency\u002Fautoimmune disease: Congenital\u002Facquired immunodeficiency or autoimmune diseases per Investigator judgement.\n14. Immunosuppressive therapy: Systemic immunosuppressants (e.g., prolonged steroids) within 3 months; inhaled\u002Ftopical steroids allowed.\n15. Severe chronic diseases: Severe cardiac, pulmonary, hepatic, renal disease, or diabetes.\n16. Coagulation issues: History of thrombocytopenia or bleeding disorders contraindicating IM injection.\n17. Fever\u002Finfection: Fever \\>38°C or active systemic infection within 7 days of vaccination.\n18. Hypertension: Abnormal or uncontrolled high blood pressure at screening (≥140\u002F90 mmHg).\n19. Known or suspected infection with HBV, HCV, or HIV.\n20. Alcohol or drug abuse, including regular alcohol intake of \\>14 drinks\u002Fweek or \\>4 drinks\u002Fday.\n21. Positive drug screen (amphetamines, barbiturates, benzodiazepines, cocaine, THC, methadone, methamphetamine, opiates, PCP, tricyclic antidepressants) or positive alcohol breath test at Screening or Day -1.\n22. Inability to assess injection site due to tattoos or skin conditions on both deltoids.\n23. Study site employees involved in the protocol or with access to study data.\n24. Any other condition that may impact participant safety or interfere with study assessments, as judged by the Investigator.","FEMALE",{"count":208,"type":19},120,[153],"A Phase 1 study to evaluate safety, tolerability and immunogenicity a RSV vaccine in healthy women 18 to 49 years of age",[23],"2026-03-19",{"date":214,"type":31},"2026-03-25",{"date":216,"type":19},"2026-04-01",{"date":218,"type":19},"2027-01-15",{"name":109,"class":38},{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":15,"minAge":227,"maxAge":228,"enrollmentInfo":229,"targetDuration":4,"studyType":49,"phases":231,"briefSummary":233,"conditions":234,"keywords":235,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":4},"100630052","phase-2-a-phase-2-study-to-investigate-the-efficacy-and-safety-of-zelicapavir-in-participants-aged-28-days-to-36-months-of-age-infected-with-respiratory-syncytial-virus-100630052","NCT07482657","A Phase 2 Study to Investigate the Efficacy and Safety of Zelicapavir in Participants Aged ≥28 Days to ≤36 Months of Age Infected With Respiratory Syncytial Virus","Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zelicapavir in Participants ≥28 Days to ≤36 Months of Age Infected With Respiratory Syncytial Virus","Inclusion Criteria:\n\n* Participants diagnosed with RSV infection using an approved diagnostic assay, without known and\u002For documented coinfection with SARS-CoV-2 or influenza\n* Participant has signs of RSV infection with onset ≤3 days (72 hours) at the time of randomization\n* In the Investigator's opinion, the participant's caregiver understands and is able to comply with protocol requirements, instructions, and restrictions, and the participant is likely to complete the study as planned. The caregiver(s) should be of legal age.\n\nExclusion Criteria:\n\n* Participant has any condition that in the opinion of the Investigator would interfere with the evaluation of the study drug or participant safety.\n* Participant has underlying immune deficiency. Participants with immunoglobulin A deficiency are not excluded.\n* Participant has had major surgery within 6 weeks prior to randomization or has major surgery planned during the course of the study.\n* Participant is currently taking either chronically or has taken within 7 days prior to randomization, or is anticipated to receive during the course of the study, systemic medications that are known to cause immunosuppression other than corticosteroids for \\>5 days.\n* Participant has received an investigational agent within the last 30 days or 5 half-lives of the investigational agent, whichever is longer.","28 Days","36 Months",{"count":230,"type":19},150,[232],"PHASE2","Zelicapavir is a novel, orally administered, nonfusion replication inhibitor of RSV. It is being investigated in this Phase 2 study (EDP 938-203) as a potential treatment for RSV infection in both hospitalized and non-hospitalized children aged ≥28 days to ≤36 months who present with symptomatic RSV infection.",[159,158,23],[158,236,237,238],"children","Respiratory Syncytial Virus","Pediatric study","2026-03-16",{"date":212,"type":31},{"date":242,"type":19},"2026-07",{"date":244,"type":19},"2026-12",{"name":246,"class":38},"Enanta Pharmaceuticals, Inc",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":15,"minAge":255,"maxAge":256,"enrollmentInfo":257,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":259,"conditions":260,"keywords":265,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":4},"100627217","tarsila-real-world-evidence-study-100627217","NCT07445763","TARSILA Real-World Evidence Study","Real-world Effectiveness of maTernAl RSVpreF vaccInation Against RSV-associated Acute Respiratory ilLness in Infants in BrAzil (TARSILA Study): a Multicentre, Prospective, Test-negative, Case-Control Study","TARSILA","Tarsila Inpatient Study\n\nInclusion Criteria\n\n* Infant born in Brazil.\n* Mother resident in Brazil during the related pregnancy.\n* Infant date of birth 14 days or more after start of the first national RSVpreF vaccination campaign to ensure potential to have been born to an RSVpreF-vaccinated mother.\n* Infant ≤360 days of age at time of RSV specimen collection.\n* Infant born at ≥37 weeks of gestational age.\n* Infant hospital admission for at least 24 hours with signs and symptoms meeting the case definition of ARI, defined as the presence of any of the following: nasal secretion for ≥24 hours; respiratory distress, labored breathing, or tachypnea (respiratory rate ≥60 breaths\u002Fmin for infants \\\u003C2 months or ≥50 breaths\u002Fmin for infants 2-12 months); cough; inability to feed for any period due to respiratory symptoms; apnea; or other relevant respiratory symptoms (examples include but are not limited to wheezing, crackles, and nasal flaring).\n\nExclusion Criteria:\n\n* Maternal or infant receipt of any other licensed or investigational RSV preventive product.\n* Infant receipt of blood transfusion or other blood products containing antibodies since birth.\n* Infant previously enrolled in this study.\n* Lack of informed consent from the mother or the infant's legal guardian.\n* Absent or inconclusive RT-qPCR result for RSV.\n* Birth to a mother whose RSVpreF vaccination status could not be confirmed.\n\nTarsila Outpatient Study\n\nInclusion Criteria:\n\n* Infant born in Brazil.\n* Mother resident in Brazil during the related pregnancy.\n* Infant date of birth 14 days or more after start of the first national RSVpreF vaccination campaign to ensure potential to have been born to an RSVpreF-vaccinated mother.\n* Infant ≤360 days of age at time of RSV specimen collection.\n* Infant born at ≥37 weeks of gestational age.\n* Infant presentation to an outpatient healthcare facility with signs and symptoms meeting the case definition of ARI, defined as the presence of any of the following: nasal secretion for ≥24 hours; respiratory distress, labored breathing, or tachypnea (respiratory rate ≥60 breaths\u002Fmin for infants \\\u003C2 months or ≥50 breaths\u002Fmin for infants 2-12 months); cough; inability to feed for any period due to respiratory symptoms; apnea; or other relevant respiratory symptoms (examples include but are not limited to wheezing, crackles, and nasal flaring).\n\nExclusion Criteria:\n\n* Mother or infant receipt of any other licensed or investigational RSV preventive product.\n* Infant receipt of blood transfusion or other blood products containing antibodies since birth.\n* Lack of informed consent from the mother or the infant's legal guardian.\n* Absent or inconclusive RT-qPCR result for RSV.\n* Birth to a mother whose RSVpreF vaccination status could not be confirmed.\n* Enrollment in the study within the previous 30 days. If the interval exceeds 30 days, infants will be excluded if any previous episode tested positive for RSV.","0 Days","360 Days",{"count":258,"type":19},5000,"The overall objective of Tarsila Study is to estimate the real-world vaccine effectiveness of maternal RSVpreF immunization during pregnancy in Brazil against medically attended (inpatient and outpatient) respiratory syncytial virus-associated acute respiratory illness in infants. To achieve this, two multicenter, prospective, test-negative case-control studies will be conducted among infants with ARI: the TARSILA Inpatient Study, evaluating hospitalized infants and the TARSILA Outpatient Study, evaluating infants managed in outpatient settings.",[23,261,262,263,264],"Maternal Immunization","Acute Respiratory Illness (ARI)","Lower Respiratory Tract Disease","Infant Outcomes",[266,267,268,269,270,271],"respiratory syncytial virus","respiratory syncytial virus bivalent prefusion F vaccine","acute respiratory illness","lower respiratory tract disease","Maternal immunization","Tarsila study","2026-02-25",{"date":274,"type":31},"2026-03-03",{"date":276,"type":19},"2026-04-30",{"date":278,"type":19},"2028-12-31",{"name":280,"class":140},"Inova Medical",{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":46,"sex":15,"minAge":288,"maxAge":289,"enrollmentInfo":290,"targetDuration":4,"studyType":49,"phases":292,"briefSummary":293,"conditions":294,"keywords":295,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":141},"100620916","phase-1-phase-ibiia-clinical-trial-of-sibp-a16-injection-in-premature-infants-and-full-term-infants-100620916","NCT07363837","Phase Ib\u002FIIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants","A Randomized, Double-blind, Placebo\u002FPositive Control, Dose-finding Phase Ib\u002FIIa Clinical Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of SIBP-A16 Injection in Premature Infants and Full-term Infants","Inclusion Criteria:\n\n* During screening, infants within 1 year of age, including premature infants (gestational age ≥29 to \\\u003C35 weeks) and full-term infants (gestational age ≥35 weeks), with underlying diseases but no other risk factors, are allowed to participate in the trial;\n* Infants with a body weight ≥3 kg at screening;\n* Infants who are entering their first RSV infection season at screening;\n* Parents\u002Flegal guardians of trial participants have signed the informed consent form;\n* Parents\u002Flegal guardians of trial participants are able to understand and comply with the requirements and procedures of the protocol, including scheduled center visits, telephone interviews, and blood sample collection;\n* Participants can complete the follow-up period, which is approximately 1 year after the administration of the study drug.\n\nExclusion Criteria:\n\n* Any fever (≥37.5°C, axillary temperature) or acute illness (defined as the presence of moderate or severe symptoms or signs) occurring within 7 days prior to drug administration;\n* Having experienced Lower Respiratory Tract Infections (LRTI) within the previous 7 days prior to randomization, or having active LRTI at the time of randomization;\n* Individuals with chronic eczema or urticaria, or those with an allergic constitution who are allergic to multiple drugs, or those with a known history of allergy to immunoglobulin products, blood products, other exogenous proteins, or any components of this product;\n* Had a history of RSV infection before randomization, or had active RSV infection at the time of randomization;\n* Those who have received non-oral inactivated vaccines or component vaccines within 7 days before administration;\n* Having received a non-oral live attenuated vaccine within 30 days prior to drug administration;\n* Participants who have received any medication within 7 days prior to drug administration, except for: a) various vitamins and iron supplements; b) systemic over-the-counter medications (such as analgesics) for common pediatric symptoms, which may be used occasionally, as determined by the investigator;\n* Participants with autoimmune diseases who are currently receiving, or are expected to receive according to the investigator's judgment, immunosuppressive therapy (including steroids, excluding topical steroids) during the trial period;\n* Have previously used or are expected to receive blood products or immunoglobulin products during the trial period;\n* Known renal dysfunction or liver dysfunction;\n* Known to have chronic lung disease (CLD)\u002Fbronchopulmonary dysplasia;\n* Congenital respiratory abnormalities with clinical significance;\n* Suffering from congenital heart disease (CHD) accompanied by significant hemodynamic changes;\n* Suffering from chronic epilepsy or progressive or unstable neurological disorders;\n* Those who have previously experienced or are suspected to have experienced life-threatening acute events, and are still deemed unsuitable for participating in clinical trials by the researchers;\n* Known immune deficiency, including infection with human immunodeficiency virus (HIV);\n* The mother is infected with HIV (unless it has been proven that the trial participant is not infected);\n* The mother received the RSV vaccine during pregnancy;\n* Have received any investigational drugs or participated in any intervention studies;\n* Any other circumstances that the researcher believes may interfere with the evaluation of the study drug or the interpretation of the study results;\n* The participants are the children of the researchers, their subordinate researchers, relatives, or staff members of the sponsor.","0 Months","12 Months",{"count":291,"type":19},36,[153,232],"This trial employs a randomized, double-blind, placebo\u002Fpositive control, and dose-finding design to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of SIBP-A16 injection in premature and term infants.",[23],[158,296,297,298,299,300],"Preliminary efficacy","Premature and term infants","Pharmacokinetics","Safety","Tolerability","2026-01-14",{"date":303,"type":31},"2026-01-23",{"date":305,"type":19},"2026-01-15",{"date":307,"type":19},"2027-03-31",{"name":309,"class":38},"Shanghai Institute Of Biological Products",{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":46,"sex":15,"minAge":317,"maxAge":318,"enrollmentInfo":319,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":321,"conditions":322,"keywords":380,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":141},"100620537","risk-assessment-of-community-spread-of-multiple-endemic-infectious-diseases-in-a-one-health-perspective-100620537","NCT07358910","Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective","RACSMEI","Inclusion Criteria:\n\n* Residency in the village for more than 6 months;\n* Age between 2 and 75 years old at the time of inclusion;\n* For adults: provision of written consent;\n* For children aged 2-17 years: written parental consent form, verbal assent from children aged 13-17 years;\n\nExclusion Criteria:\n\n* Unable to understand or consent;\n* Under guardianship or deprived of liberty;\n* Medical conditions that impede survey participation;\n* Refusal to participate in the study.","2 Years","75 Years",{"count":320,"type":19},10000,"RACSMEI addresses the high burden of infectious diseases in low- and middle-income countries, including Cambodia, where limited surveillance and laboratory capacity often obscure etiologies and transmission dynamics. This knowledge gap hinders the design of effective prevention and control strategies.\n\nRACSMEI will improve understanding across multiple pathogens using a multidisciplinary One Health approach. We will answer key questions on burden, ecology, transmission and population immune status to inform targeted and culturally appropriate interventions. The project combines a nationally representative One Health survey, social-science methods, and multiplex, diverse diagnostics to efficiently test for 57 priority pathogens, including zoonotic and vector-borne agents, vaccine-preventable and elimination-targeted diseases, enteric, respiratory, and environmentally transmitted pathogens and selected neglected tropical diseases and parasites relevant to Cambodia.\n\nMathematical modelling will reconstruct and forecast transmission dynamics and assess the potential impact of future public-health strategies. By integrating intersectoral data and innovative methods, RACSMEI will generate actionable evidence for public-health authorities, support precision One Health interventions, and help reduce disease burden in affected communities. The project also aims to ensure the transferability of methods and insights to other countries facing similar challenges.",[323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,23,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377,378,379],"Dengue","Chikungunya","Zika Virus Infection","Japanese Encephalitis","West Nile Virus","Tick-borne Encephalitis (TBE)","Severe Fever With Thrombocytopenia Syndrome","Nipah Virus Infection","Hantavirus Infections","Hepatitis E","Brucellosis","Q Fever","Leptospirosis","Melioidosis","Influenza A and B","Malaria","Yellow Fever","Mayaro Fever","Usutu Virus Infection","Oropouche Fever","Rift Valley Fever","Arenavirus Infections","Measles","Mumps","Rubella","Human Papilloma Virus (HPV)","Rotavirus Disease","Pertussis","Diphteria","Tetanus","Varicella","Hepatitis A","Norovirus Infections","Enterovirus","Adenovirus","Rhinovirus","Parvovirus","Cytomegalovirus","Epstein Barr Virus","Salmonella Typhi","Vibrio Cholerae","Legionella Pneumophila Pneumonia","Mycoplasma","Chlamydia","Lymphatic Filariasis","Toxoplasma Gondii","Giardiasis","Entamoeba Histolytica","Leishmaniasis","Strongyloides Stercoralis Infection","Ascaris Lumbricoides","Trichuris Trichiura","Clonorchis Sinensis","Opisthorchis Viverrini","Schistosomiasis","Streptococcus Pneumoniae","Meningitis",[381,382,383,384,385,386,387,388,389,390,391,392,393,394,395,396,397],"Infectious disease","One Health","Population-based survey","Nationally representative survey","Seroepidemiology","Multiplex serology","Seroprevalence","Vector-borne diseases","Zoonoses","Vaccine-preventable diseases","Neglected tropical diseases","Transmission dynamics","Force of infection","Mathematical modelling","Spatial epidemiology","Precision public health","Cambodia",{"date":399,"type":31},"2026-01-22",{"date":401,"type":31},"2025-12-18",{"date":403,"type":19},"2027-09-30",{"name":405,"class":140},"Institut Pasteur du Cambodge",{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":412,"eligibilityCriteria":413,"healthyVolunteers":46,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":49,"phases":416,"briefSummary":417,"conditions":418,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":141},"100596842","phase-2-immunogenicity-of-rsvpref3-vaccine-in-immunocompromised-persons-100596842","NCT07050732","Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons","Immunogenicity and Safety of Multiple-Dose Adjuvanted RSVPreF3 (Arexvy®) Vaccination Among Immunocompromised Persons","STRIVE","Inclusion Criteria:\n\n* Able to understand and provide informed consent\n* Willing and able to comply with the requirements and restrictions in the protocol, including study visits and study-related procedures\n* Medically stable in the opinion of the Investigator at the time of first study vaccination\n* Life expectancy ≥ 365 days in the opinion of the Investigator at the time of first study vaccination\n* Included in at least one of the groups below:\n\n  1. Cellular therapy recipients (CTR):\n\n     * Individuals ≥ 18 years of age at the time of first study vaccination\n     * History of at least one of the following: i. Autologous stem cell transplant received more than 90 days prior to first study vaccination, ii. Allogeneic stem cell transplant received more than 90 days prior to first study vaccination, iii. Chimeric antigen receptor T cell (CAR-T) therapy received more than 90 days prior to first study vaccination\n  2. Solid organ transplant recipients (SOTR):\n\n     * Individuals ≥ 18 years of age at the time of first study vaccination\n     * Received an ABO-compatible, single-organ type, solid organ transplant (lung, heart, kidney, liver) at least 90 days prior to first study vaccination, and are on at least 2 systemic immunosuppressive agents at time of first study vaccination\n  3. Healthy comparator (HC):\n\n     * Individuals ≥ 60 years of age at the time of first study vaccination or 50-59 years of age at the time of first study vaccination and at increased risk of severe RSV disease\n     * No history of (a) or (b) above, and considered healthy or with chronic and stable medical conditions in the opinion of the Investigator, without immune compromise\n* Participants of childbearing potential if practicing adequate contraception or abstinence from 1 month prior to first study vaccination and agree to continue adequate contraception or abstinence through at least 1 month after last study vaccination. All participants of childbearing potential must have a negative pregnancy test on the day of first study vaccination, prior to administration.\n\nExclusion Criteria:\n\n* Known history of hypersensitivity to any vaccine or history of a life-threatening reaction to a vaccine\n* Previous vaccination with any licensed or investigational RSV vaccine\n* Acute or chronic clinically significant\u002Funstable neurological disease (such as uncontrolled seizures, strokes, Guillain-Barré Syndrome (GBS)\n* Vaccination with any inactivated, subunit, or split influenza vaccine or COVID-19 vaccine within 14 days prior to first study vaccination, or vaccination with any other licensed or investigational vaccine within 30 days prior to first study vaccination\n* Receipt of investigational or approved monoclonal antibodies against RSV within 90 days prior to first study vaccination\n* Moderate or severe acute illness\u002Finfection (in opinion of the Investigator) or febrile illness (temperature ≥ 38.0°C \\[≥ 100.4°F\\]) on the day of first study vaccination. A prospective participant should not be enrolled in the study until the condition has resolved or the febrile event has subsided.\n* Any medical condition that in the opinion of the Investigator would make intramuscular injection unsafe\n* Receipt of immunoglobulins or plasma products within 90 days prior to first study vaccination\n* Receipt of B-cell depleting medications (e.g., Rituximab, ocrelizumab, ofatumumab, belimumab, epratuzumab, antithymocyte globulin) within 90 days prior to first study vaccination\n* Currently pregnant or breastfeeding or planning to become pregnant, discontinue contraception, or breastfeed during the study period\n* Any of the following:\n\n  1. Cellular therapy recipients (CTR):\n\n     * Graft-versus-host disease (GVHD) requiring systemic treatment with at least 0.5 mg\u002Fkg per day of prednisone or equivalent at time of first study vaccine\n  2. Solid organ transplant recipients (SOTR):\n\n     * History of any of the following within 90 days prior to first study vaccination: allograft rejection, post-transplant lymphoproliferative disease, treatment for either of these conditions\n  3. Healthy comparator (HC):\n\n     * Any confirmed\u002Fsuspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive or cytotoxic therapy, based on medical history\n* Any other conditions which, in the opinion of the Investigator, may pose additional risks from participation in the study, may interfere with the individual's ability to comply with study requirements or may impact the quality or interpretation of the data obtained from the study",{"count":415,"type":19},170,[232],"This clinical trial is being done to learn more about how well a vaccine (Arexvy®) for respiratory syncytial virus, also known as RSV, works in people with weakened immune systems. The main questions it aims to answer are:\n\n* Does 1 or 2 doses of Arexvy work better in people with weakened immune systems?\n* What medical problems do participants have after receiving Arexvy?\n\nParticipants with weakened immune systems will:\n\n* Receive 3 study vaccines over the course of 1 year\n* Keep a diary of symptoms for 7 days after each vaccine\n* Have 3 in-person follow up study visits for checkups and tests over the course of 1.5 years\n* Have 6 phone follow up study visits over the course of 1.5 years",[23],"2025-12-05",{"date":421,"type":31},"2025-12-12",{"date":423,"type":31},"2025-12-04",{"date":425,"type":19},"2028-04",{"name":427,"class":140},"Johns Hopkins University",{"id":429,"slug":430,"hasResults":11,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":4,"eligibilityCriteria":434,"healthyVolunteers":46,"sex":15,"minAge":435,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":49,"phases":438,"briefSummary":439,"conditions":440,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":447,"locationsCount":448},"100613887","phase-3-phase-iii-clinical-trial-of-the-recombinant-respiratory-syncytial-virus-vaccine--cho-cell-100613887","NCT07272434","Phase III Clinical Trial of the Recombinant Respiratory Syncytial Virus Vaccine ( CHO Cell)","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) in Adults Aged 60 Aears and Above","Inclusion Criteria:\n\n1. A male or female can provide legal identification at the time of enrollment, and is 60 years of age or older (women are required to be infertile).\n\n   (Note: Women with infertility include those who have been menopausal or have undergone sterilization (including hysterectomy, bilateral salpingectomy, bilateral oophorectomy, etc.)\n2. Be able to understand the trial procedures, risks and benefits and voluntarily agree to participate in the study and sign an informed consent.\n3. Be able to participate in all scheduled visits and comply with the protocol requirements\n4. Participants with stable health conditions considered by the investigator. Stable health conditions refer to patients with chronic diseases whose conditions are stable (regardless of whether they have received specific treatment or not), such as diabetes, hypertension, chronic obstructive pulmonary disease, asthma, etc. If the researcher determines that the condition is stable, they may be allowed to participate in this trial.\n\nExclusion Criteria:\n\nParticipants who meet any of the following exclusion criteria will not be allowed to enter the study (if the number of participants is not yet met, if the criteria described in \"\\*\" are met during screening, repeated screening may be performed)\n\n1. \\*Axillary temperature\\>37.3℃.\n2. History of RSV infection within 6 months before enrollment.\n3. \\*New onsets of respiratory tract infection symptoms like cough, sputum, shortness of breath, wheezing, fever, runny nose or nasal congestion within 7 days before enrollment.\n4. \\*Acute diseases or acute exacerbation of chronic disease within 3 days before vaccination.\n5. \\*Within 3 days before enrollment, antipyretic and analgesic drugs (except enteric-coated aspirin tablets for the prevention of cardiovascular and cerebrovascular diseases) and antihistamines were used\n6. Those who are allergic to the known components in the test vaccine \\[saponin (QS-21), dioleoyl phosphatidylcholine (DOPC), cholesterol, sucrose, sodium dihydrogen phosphate, anhydrous sodium dihydrogen phosphate, polysorbate 80, sodium chloride, hydrochloric acid and sodium hydroxide\\] Those who have a history of severe allergies after any vaccination or medication use \\[such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), severe urticaria, etc.\\] or serious adverse reactions.\n7. Asplenia or functional asplenia, and any condition leading to asplenia or splenectomy.\n8. Those who have had or are currently suffering from malignant tumors (except for clinically cured carcinoma in situ and papillary thyroid carcinoma).\n9. Patients are diagnosed with autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease and autoimmune thyroid disease.\n10. Persons with known or suspected immunodeficiency disorders \\[e.g. primary or secondary immunodeficiency, or diagnosed with congenital or acquired immunodeficiency, human immunodeficiency virus infection or immunosuppressive\u002Fcytotoxic agent therapy (e.g. cancer chemotherapy, organ transplantation or autoimmune disease treatment) resulting in confirmed or suspected immunosuppression or immunodeficiency\\].\n11. According to the investigator's assessment,there is any disease that may make intramuscular injections unsafe, such as a history of thrombocytopenia or other coagulation disorders.\n12. Those who have a history or are currently suffering from severe clinical diseases that have not been cured (such as severe cardiovascular and cerebrovascular diseases, liver and kidney diseases, respiratory system diseases, diabetes with complications, major surgeries, etc.) and may affect the evaluation of the trial.\n13. Those who have had or are currently suffering from thrombotic diseases.\n14. Patients with a history of untreated TB or active TB at enrollment.\n15. \\*Hypertension with poor medication control (on-site blood pressure measurement before vaccination: systolic blood pressure≥150mmHg and\u002For diastolic blood pressure≥100mmHg).\n16. Those with severe arrhythmias (such as atrial fibrillation).\n17. Those with a history or family history of convulsions, epilepsy, congenital brain hypoplasia, mental illness, etc., or a history of brain nerve tissue damage caused by other serious neurological diseases (such as brain tumors, cerebral hemorrhage, brain infections, chemical drug poisoning, etc.).\n18. Use of any experimental or unapproved product (drug, vaccine or medical device) other than the vaccine used in this trial or participate in other clinical trials within 30 days prior to enrollment or during the trial period.\n19. \\*Within 14 days prior to enrollment, any non-live vaccine has been administered, or within 28 days, a live vaccine or nucleic acid vaccine has been administered.\n20. Has received the RSV vaccine before.\n21. Use of immunoglobulin and\u002For any blood preparation or plasma derivative, such as gamma globulin or intravenous human immunoglobulin, within 3 months prior to enrollment or plan to use during the trial\n22. Within the 3 months prior to enrollment or if it is expected to be used for a long period during the trial (continuous for more than 14 days), immunosuppressive agents or other immunomodulatory drugs (such as long-term use of systemic glucocorticoids for ≥ 14 days, with a dose of ≥ 20mg\u002Fday prednisone or equivalent prednisone dose; local medications are allowed, such as ointments, eye drops, inhalants or nasal sprays, but the local medication dosage must not exceed the recommended dosage in the instructions)\n23. Long-acting immunomodulatory drugs (such as infliximab) were used within 6 months before enrollment or during the planned trial period.\n24. The researchers determined that the drinking behavior and\u002For drug abuse history that might affect the assessment of the trial (Note: within the last three months, men had an average of more than 14 standard drinks per week, and women had an average of more than 7 standard drinks per week; 1 standard drink contained 14g of alcohol, such as 360mL of beer or 45mL of 40% alcohol spirit or 150ml of wine.) Drug abuse refers to the repeated and excessive use of drugs with dependent characteristics or potential for dependence, which is not related to recognized medical needs and falls under non-medical purpose drug use.\n25. Planned move to a location that will prohibit participating in the trial until study end;\n26. Any condition that, in the opinion of the investigator, may affect the safety of the participant or the evaluation of the study results.","60 Years",{"count":437,"type":19},25000,[51],"This study will evaluate the efficacy of the Recombinant RSV vaccine(CHO cell) vaccine in preventing lower respiratory tract diseases(LRTD) caused by RSV in adults≥ 60 years of following a single dose of the RSV vaccine(CHO cell) vaccine .This study will also assess if the vaccine is safe and induces an immune response.",[23],"2025-11-26",{"date":443,"type":31},"2025-12-09",{"date":445,"type":31},"2025-10-22",{"date":278,"type":19},{"name":109,"class":38},8,{"id":450,"slug":451,"hasResults":11,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":4,"eligibilityCriteria":455,"healthyVolunteers":46,"sex":15,"minAge":16,"maxAge":456,"enrollmentInfo":457,"targetDuration":4,"studyType":49,"phases":459,"briefSummary":461,"conditions":462,"keywords":463,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":141},"100601163","early-phase-1-a-clinical-trial-of-sibp-a16-injection-in-healthy-adults-100601163","NCT07106918","A Clinical Trial of SIBP-A16 Injection in Healthy Adults","A Randomized, Double-blind, Placebo\u002FPositive Control Phase Ia Clinical Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of SIBP-A16 Injection in Healthy Adults","Inclusion Criteria:\n\n* Healthy individuals aged 18 to 45 on the day of enrollment, regardless of gender.\n* Male body weight ≥ 50.0 kg, female body weight ≥ 45.0 kg, BMI between 19.0 and 27.0 kg\u002Fm2 (including critical values).\n* Screening period physical examination, vital sign examination, 12 lead electrocardiogram, chest X-ray or clinical laboratory examination, and other auxiliary examination results show normal or abnormal without clinical significance as judged by the researcher.\n* Individuals who voluntarily participate in clinical trials and sign informed consent forms.\n* Individuals are able to communicate well with the researchers and understand and comply with the requirements of this study.\n\nExclusion Criteria:\n\n* Known to have a history of serious clinical diseases such as mental system, circulatory system, endocrine system, digestive system, respiratory system, hematological and metabolic abnormalities, or any other diseases that can interfere with the test results.\n* Individuals with a history of drug allergies or specific allergies, or individuals with allergies, or those known to be allergic to the components or analogues of this drug.\n* During the screening period, individuals with abnormal results from physical examination, laboratory tests and clinical significance were identified by the researchers as having an impact on the evaluation of this trial.\n* During the screening period, male individuals with QTcF ≥ 450 milliseconds and female individuals with QTcF ≥ 470 milliseconds on electrocardiogram.\n* Individuals who have received monoclonal\u002Fpolyclonal antibody drugs within 6 months prior to screening.\n* Individuals have received immunoglobulin or blood product treatment within 6 months prior to screening.\n* Individuals who have received passive immune agents, immunosuppressants, or corticosteroids within the 6 months prior to screening.\n* Individuals who experience acute illnesses such as fever ≥ 37.3 ℃ (armpit temperature) and diarrhea within one week before their first medication.\n* Individuals experienced symptoms and signs of acute upper respiratory tract infection within 2 weeks prior to the first use of medication.\n* Individuals who have received the respiratory syncytial virus (RSV) vaccine in the past.\n* Individuals have received any vaccine within 30 days prior to screening.\n* Select individuals who have smoked at least 5 cigarettes per day within the first 3 months and those who cannot quit smoking throughout the entire trial period.\n* Individuals with an average weekly alcohol consumption of ≥ 14 units within the first 3 months of screening, or those who cannot abstain from alcohol during the trial period.\n* Individuals have a history of long-term excessive consumption of tea, coffee, or caffeinated beverages.\n* Individuals have used any medication or health supplement within the 14 days prior to screening.\n* Individuals with a history of drug abuse\u002Fdependence or drug use within the past year prior to screening.\n* Screening individuals who have participated in any drug clinical trials and have used the investigational drug within the previous 3 months.\n* Individuals with a history of blood donation or significant bleeding within the previous 4 weeks prior to screening, or those planning to donate blood or blood components during the study period.\n* Pregnant or lactating women.\n* Those who have plans to conceive, donate sperm or eggs, or are unable to voluntarily take effective contraceptive measures during the trial period (including partners).\n* Those who have special dietary requirements and cannot follow a reasonable and normal diet.\n* The researchers believe that the individuals may have other situations that may affect compliance or be unsuitable to participate in this trial","45 Years",{"count":458,"type":19},140,[460],"EARLY_PHASE1","This study is a randomized, double-blind, placebo\u002Fpositive control Phase Ia clinical trial evaluating the safety, tolerability, and pharmacokinetics of SIBP-A16 injection in healthy adults",[23],[464,465,466,467,468],"Respiratory syncytial virus","SIBP-A16","safety","tolerability","pharmacokinetics","2025-11-19",{"date":471,"type":31},"2025-11-25",{"date":473,"type":31},"2025-08-17",{"date":475,"type":19},"2027-04-30",{"name":309,"class":38},{"id":478,"slug":479,"hasResults":11,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":483,"eligibilityCriteria":484,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":49,"phases":487,"briefSummary":488,"conditions":489,"keywords":493,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":506},"100442763","phase-4-antibiotic-therapy-in-viral-airway-infections-100442763","NCT05045612","Antibiotic Therapy in Viral Airway Infections","Antibiotic Therapy in Viral Airway Infections: An Open Labeled Randomized Controlled Pragmatic Trial to Evaluate the Efficacy and Safety of Discontinuing Antibiotic Therapy in Adult Patients With Respiratory Viruses","ATHENIAN","Inclusion Criteria:\n\n* Hospitalized\n* Adults 18 year or older\n* Moderately severe disease (CRB65 ≤ 2 at time of inclusion)\n* Nasopharyngeal swab positive for influenza virus, parainfluenza virus, respiratory syncytial virus (RSV) or human metapneumovirus (hMPV)\n* On antibiotic therapy as instituted by the receiving physician from the emergency department\n* Signed informed consent must be obtained and documented according to ICH GCP, and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* Requiring ICU admission at screening\n* Requiring high-flow oxygen therapy or non-invasive ventilation at screening\n* Signs of severe pneumonia (abscesses, massive pleural effusion, a well-defined lobar infiltrate on chest X-ray strongly suggestive of bacterial etiology)\n* Not immunocompetent (i.e. on active chemotherapy, corticosteroid therapy equaling ≥ 20 mg prednisolone daily for ≥ 4 weeks, chronic immunosuppression due to solid organ transplant)\n* SARS-CoV-2 positive\n* Bacteremia\n* Urine antigen test positive for legionella\n* Any other infection necessitating antibiotic treatment\n* Antibiotic use for assumed airway infection within the last 24 hours before admission to hospital\n* Time from initiation of antibiotic therapy to screening \\>48 hours",{"count":486,"type":19},380,[123],"Antimicrobial resistance is one of the most urgent health threats of our time, and Norwegian hospitals were required to reduce the use of broad-spectrum antibiotics with 30% by the end of 2020. In the current proposal, the investigators aim to assess the efficacy and safety of early discontinuation of antibiotic therapy in adult patients infected with respiratory viruses.\n\nA general recommendation to treat all instances of community acquired pneumonia (CAP) patients with antibiotics leads to significant antibiotic overtreatment. In 2008, the US Food and Drug Administration approved the first multiplex polymerase chain reaction assay for the detection of multiple respiratory virus nucleic acids simultaneously. The wide availability of such nucleic acid amplification tests (NAAT) for rapid viral detection together with chest radiographs has the potential to define patients who can be managed without antibiotics.\n\nAkershus University Hospital is one of the largest hospitals in Norway, with a catchment area of more than 550,000 people. In 2012 to 2013, the majority of patients admitted to Akershus University Hospital with suspected CAP and a positive viral NAAT were treated with antibiotics, a prescription pattern representing antibiotic overtreatment. The investigators accordingly hypothesize that discontinuation of antibiotic therapy in patients with moderately severe disease and airway sample positive for respiratory viruses is safe and non-inferior to continuation of antibiotic therapy.",[490,491,23,492],"Infectious Disease","Influenza","Respiratory Tract Infections",[494,495,496],"pragmatic trial","antibiotic stewardship","viral respiratory tract infection","2025-08-11",{"date":499,"type":31},"2025-08-12",{"date":501,"type":31},"2022-01-13",{"date":503,"type":19},"2029-11",{"name":505,"class":140},"University Hospital, Akershus",12,{"id":508,"slug":509,"hasResults":11,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":513,"eligibilityCriteria":514,"healthyVolunteers":11,"sex":15,"minAge":255,"maxAge":317,"enrollmentInfo":515,"targetDuration":4,"studyType":49,"phases":516,"briefSummary":517,"conditions":518,"keywords":519,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":448},"100583231","phase-2-safety-pharmacokinetics-and-antiviral-activity-of-remdesivir-veklury-in-hospitalized-children-with-rsv-100583231","NCT06873633","Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV","A Phase II Study to Evaluate the Safety, Pharmacokinetics, Antiviral Activity and Acceptability of Remdesivir (VEKLURY®) in Hospitalized Children Aged 0 to Less Than 2 Years With Respiratory Syncytial Virus (RSV)-Associated Lower Respiratory Tract Infection.","THAI-CARES RSV","Inclusion Criteria:\n\n* Signed informed consent from parents\u002Fcaregivers\n* Aged 0 to \\\u003C2 years\n* Weighing at least 2.0 kg\n* Onset of RSV associated-symptoms within 1 week of screening\n* Confirmed\\* with RSV infection (by rapid antigen test or RT PCR)\n* Hospitalized children fulfilling at least two of the following three RSV disease severity criteria:\n\n  * Inadequate oral feeding\n  * Inadequate oxygen saturation (peripheral capillary oxygen saturation \\[SpO2\\] \\\u003C95% on room air or requiring oxygen supplementation to maintain SpO2 ≥95%)\n  * Signs of respiratory distress (respiratory rate of ≥60 breaths per min for children aged up to 1 year, or ≥40 breaths per min for those older than 1 year, or accessory respiratory muscles use \\[subcostal, intercostal, or suprasternal retraction\\], or both)\n\nExclusion Criteria:\n\n* Preterm infants (gestational age at birth less than 37 weeks) who are aged \\\u003C56 days\n* Being hospitalized for other clinically relevant concurrent conditions (except for risk factors for severe RSV, e.g., cardiac disease, pulmonary disease, genetic disease, and prematurity)\n* Concurrent treatments with other agents with actual or possible direct antiviral activity against RSV \\\u003C24 hours prior to study drug dosing (e.g. ribavirin)\n* ALT or AST \\> 5 × ULN\n* eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2 using the Schwartz formula if aged ≥1 year; or if aged \\\u003C1 year based on a creatinine value cut off dependent on chronological age\n* Any major congenital renal anomaly if \\\u003C28 days\n* Apgar score \\\u003C 5 when last recorded if age \\\u003C24 hours\n* Known hypersensitivity to the study drug, the metabolites, or formulation excipient.\n* On renal replacement therapies (e.g., intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy)\n* Any condition that, in the opinion of the site investigator, would make participation in the study unsafe for the child, or comprise the study objectives",{"count":208,"type":19},[232],"THAI-CARES RSV Study is a Phase II, open-label, multicenter, randomized controlled trial with a two-arm, parallel-group design. The study aims to assess the safety, efficacy, and acceptability of a five-day course of Remdesivir (VEKLURY®) in children under two years of age who are hospitalized with confirmed respiratory syncytial virus (RSV) infection, as determined by either a rapid antigen test or RT-PCR. The primary objectives include evaluating the treatment's safety profile, its ability to significantly reduce RSV replication, and its overall acceptance in this patient population.",[23],[520,521,522],"respiration disorders","RSV infection","Respiratory Syncytial Virus Hospitalizations","2025-07-18",{"date":525,"type":31},"2025-07-23",{"date":527,"type":31},"2025-07-16",{"date":529,"type":19},"2027-02",{"name":531,"class":532},"PENTA Foundation","NETWORK",{"id":534,"slug":535,"hasResults":11,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":11,"sex":15,"minAge":540,"maxAge":541,"enrollmentInfo":542,"targetDuration":4,"studyType":49,"phases":544,"briefSummary":545,"conditions":546,"keywords":547,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":197},"100583801","peginterferon--2b-injection-for-aerosol-therapy-in-pediatric-respiratory-syncytial-virus-pneumonia-100583801","NCT06881056","Peginterferon α-2b Injection for Aerosol Therapy in Pediatric Respiratory Syncytial Virus Pneumonia","A Phase 2 Multicenter, Randomized, Open-label Study to Evaluate the Pharmacokinetic, Safety and Efficacy of Peginterferon Alfa-2b Injection in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea.","Inclusion Criteria:\n\n* (1)Age: 1 year ≤ age ≤ 3 years; (2) Gender: Both male and female participants are eligible; (3) According to the 9th edition of \"Zhu Fute's Practical Pediatrics,\" meet the following diagnostic criteria: a. RSV test positive; b. Clinical manifestations: Fever, cough, wheezing; c. Physical signs: Rapid breathing and moist rales in the lungs; (4) Time: The time from the onset of the child's illness to the signing of the informed consent form is within 72 hours (starting from the occurrence of any symptom such as fever, cough, or wheezing); (5) Informed consent: The legal guardian of the child understands and signs the informed consent form (if the legal guardians are the parents, both parents need to sign together).\n\nExclusion Criteria:\n\n* (1) Presence of any of the following clinical symptoms before enrollment: a. Poor general condition, with altered consciousness, refusal to eat, or signs of dehydration; b. Hypoxemia: Presence of cyanosis, rapid breathing (RR ≥ 50 breaths per minute), stridor, nasal flaring, tracheal tug, oxygen saturation \\\u003C 92%, and intermittent apnea; c. Extrapulmonary complications; d. Chest X-ray or CT: Multilobar lung infiltrates, pleural effusion, pneumothorax, atelectasis, lung necrosis, and lung abscess; e. Hyperpyrexia: Persistent high fever for more than 5 days; f. Presence of critical complications such as respiratory failure and circulatory failure; (2) Allergy history and treatment history: a. Receiving antiviral drug treatment with interferon, ribavirin, acyclovir, ganciclovir, or vidarabine monophosphate within 30 days before screening or currently; b. Receiving immunoglobulin treatment within 30 days before screening or currently; c. Known hypersensitivity to interferon or its components, or a clear history of other allergies that make participation in this study inappropriate; d. Use of other investigational drugs within 3 months before screening or within 5 half-lives (whichever is longer), or currently participating in a clinical trial for a medical device at the time of screening; (3) Disease history and current medical history: a. History of congenital heart disease, severe malnutrition, abnormal immune system function, or other serious diseases of major organ systems; b. Severe liver or renal dysfunction; c. History of viral infections such as HBV, HCV, HIV; d. Past or current history of malignant tumors; e. Past history of epilepsy, or history and family history of neurological\u002Fpsychiatric disorders; (4) Other conditions: Subjects deemed unsuitable for participation in this trial by the investigator.","1 Year","3 Years",{"count":543,"type":19},90,[99],"This is a multicenter, randomized, open-label, parallel-controlled, prospective clinical study. It aims to evaluate the efficacy and safety of aerosolized Peginterferon α-2b injection in the treatment of pediatric respiratory syncytial virus pneumonia. The overall study is divided into a screening period, a treatment period, and a follow-up period. Eligible children with respiratory syncytial virus pneumonia will be randomly assigned to the experimental group 1, experimental group 2, and the control group at a ratio of 1:1:1.",[23],[23,548],"Peginterferon α-2b injection","2025-03-11",{"date":551,"type":31},"2025-03-18",{"date":553,"type":31},"2024-07-17",{"date":555,"type":19},"2026-03-31",{"name":557,"class":140},"West China Second University Hospital",{"id":559,"slug":560,"hasResults":11,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":564,"eligibilityCriteria":565,"healthyVolunteers":46,"sex":206,"minAge":16,"maxAge":566,"enrollmentInfo":567,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":569,"conditions":570,"keywords":571,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":141},"100556196","rsv-vaccine-pregnancy-registry-100556196","NCT06521944","RSV Vaccine Pregnancy Registry","CorEvitas RSV Vaccine Pregnancy Registry (RSV-PR)","RSV-PR","Inclusion Criteria:\n\n* Individuals must meet the following inclusion criteria to be eligible for inclusion in the study:\n\n  1. A resident of the US at enrollment\n  2. 18 to 50 years of age at enrollment\n  3. Gestational age of ≥32 weeks, 0 days at enrollment\n  4. If exposed to RSV vaccine, receipt of any RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation\n  5. Evidence of a personally signed and dated informed consent document or, upon waiver of written consent by the relevant IRB\u002Findependent ethics committee, verbal consent indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the study\n  6. Authorization obtained for the relevant HCP(s) to provide data to the registry\n  7. Contact information available (for participant and HCPs)\n\nExclusion Criteria:\n\n* Individuals meeting any of the following criteria will not be included in the study:\n\n  1. Receipt of an RSV vaccine during pregnancy before 32 weeks, 0 days gestation\n  2. Multi-fetal pregnancy\n  3. Enrolled in the RSV-PR with a previous pregnancy","50 Years",{"count":568,"type":19},2062,"The research question is: What is the risk of adverse pregnancy outcomes, including preterm birth, hypertensive disorders, and other maternal and neonatal\u002Finfant outcomes, following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation in the CorEvitas Respiratory Syncytial Virus Vaccine Pregnancy Registry (RSV-PR)? The primary study objective is to estimate the risk of (1) preterm birth and (2) hypertensive disorders following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation.\n\nThe secondary study objective is to estimate the risk of other safety outcomes of interest following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including:\n\n* Pregnancy-related outcomes: stillbirth, premature labor, premature rupture of membranes, preterm premature rupture of membranes, cesarean delivery, prolonged maternal duration of hospital stay\n* Maternal outcomes: thrombocytopenia, Guillain-Barré syndrome, other immune-mediated demyelinating conditions, polyneuropathies, atrial fibrillation, maternal death\n* Neonatal\u002Finfant outcomes: small for gestational age, large for gestational age, low birth weight, admission to a neonatal intensive care unit (NICU), NICU duration of stay, mechanical ventilation in neonatal period, neonatal death, postnatal growth at 1 year of age The exploratory study objective is to describe the most frequently reported maternal adverse events following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation.",[23],[572,573,158,160,237,574,575,576,577],"Pregnant","Registry","Infections","Virus Diseases","Lung Diseases","Respiratory Tract Diseases","2024-07-23",{"date":580,"type":31},"2024-07-26",{"date":582,"type":31},"2024-06-28",{"date":584,"type":19},"2030-09-30",{"name":586,"class":532},"CorEvitas"]