[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"respiratory-syncytial-virus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:respiratory-syncytial-virus":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100608334","a-post-marketing-surveillance-study-of-beyfortus-nirsevimab-in-republic-of-korea-100608334",false,"NCT07200206","A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea","A Prospective, Single-arm, Non-interventional, Multi-center, Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea","Inclusion Criteria:\n\n* Children up to 24 months of age who received Beyfortus according to the approved indications.\n* Informed consent signed by the parents \u002F legally accepted representatives (LARs) of the participant.\n\nExclusion Criteria:\n\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 another clinical study investigating a vaccine, drug, medical device or a medical procedure.\n* Any contraindications according to the approved local product label of Beyfortus.",true,"ALL","0 Days","24 Months",{"count":21,"type":22},3000,"ESTIMATED","OBSERVATIONAL","This study is conducted as part of the local risk management plan to collect and understand the following information about the surveillance drug under the real-world clinical practice settings.\n\nTo evaluate the safety of Beyfortus in Korean children who received Beyfortus under the real-world clinical practice settings per the approved indication. The investigator will decide whether to enroll participants if they determine that administering Beyfortus according to current practice can provide clinical benefits in terms of safety and efficacy Participants will be followed-up for 180 days after Beyfortus administration.",[26],"Respiratory Syncytial Virus","RECRUITING","2025-11-25",{"date":30,"type":31},"2025-12-03","ACTUAL",{"date":33,"type":31},"2025-10-02",{"date":35,"type":22},"2029-09-26",{"name":37,"class":38},"Sanofi","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100553608","phase-2-assessing-antiviral-treatments-in-early-symptomatic-rsv-100553608","NCT06488300","Assessing Antiviral Treatments in Early Symptomatic RSV","Assessment of Respiratory SYNcytial Virus antivirALs: A Phase 2 Multi-centre Adaptive Randomised Platform Trial For the Assessment of Antiviral Pharmacodynamics in aCute Symptomatic RSV Infection (ARSYNAL-FC)","ARSYNAL-FC","Inclusion Criteria:\n\n* Patient understands the procedures and requirements and is willing and able to give informed consent for full participation in the study\n* Adults, male or female, aged ≥18 to \\\u003C65 years at time of consent\n* Early symptomatic RSV; at least one reported symptom of RSV (including fever, history of fever, myalgias, headache, cough, fatigue, nasal congestion, rhinorrhoea and sore throat) within 4 days (96 hours)\n* RSV positive by rapid antigen test OR a positive RT-PCR test for RSV viruses within the last 24hrs with a Ct value of \\\u003C30\n* Able to walk unaided and unimpeded in activities of daily living (ADLs)\n* Agrees and is able to adhere to all study procedures, including availability and contact information for follow-up visits\n\nExclusion Criteria:\n\nThe patient may not enter the study if ANY of the following apply:\n\n* Taking any concomitant medications or drugs which could interact with the study medications or have antiviral activity\n* Presence of any chronic illness\u002Fcondition requiring long term treatment or other significant comorbidity\n* BMI ≥35 Kg\u002Fm2\n* Clinically relevant laboratory abnormalities discovered at screening\n\n  * Haemoglobin \\\u003C10g\u002FdL (\\\u003C12g\u002FdL for all arms if Ribavirin is in the randomisation)\n  * Platelet count \\\u003C100,000\u002FuL\n  * ALT \\> 2x ULN\n  * Total bilirubin \\>1.5 x ULN\n  * eGFR \\\u003C70mls\u002Fmin\u002F1.73m2\n* For females: pregnancy, actively trying to become pregnant or lactating (women on OCP are eligible to join)\n* Contraindication to taking, or known hypersensitivity reaction to any of the proposed therapeutics\n* Currently participating in another interventional RSV, influenza or COVID-19 therapeutic trial\n* Clinical evidence of pneumonia- e.g., shortness of breath, hypoxaemia, crepitations (imaging not required)\n* Known to be currently co-infected with influenza or SARS-CoV-2 (i.e. confirmed with positive ATK or RT-PCR)\n* Received any RSV vaccine within the last year","18 Years","64 Years",{"count":51,"type":22},1000,"INTERVENTIONAL",[54],"PHASE2","This trial will use a previously validated platform, to quantitatively assess antiviral effects in low-risk patients with high viral burdens and uncomplicated Respiratory Syncytial Virus (RSV), to determine in-vivo antiviral activity. In this randomised, open-label, controlled, group sequential adaptive platform trial, we will assess and compare the performance of currently licensed interventions (including repurposed drugs) with activity against RSV, and those with potential activity demonstrated in pre-clinical and early clinical studies relative to each-other, and the control (no antiviral treatment).\n\nARSYNAL-FC study is funded by Wellcome Trust Grant ref: 226933\u002FZ\u002F23\u002FZ through the COVID-19 Therapeutics Accelerator",[26,57],"Respiratory Syncytial Virus, Human",[26,59,60],"Phase 2","Antiviral Pharmacodynamics","2025-06-27",{"date":63,"type":31},"2025-07-02",{"date":65,"type":31},"2024-07-25",{"date":67,"type":22},"2027-01-01",{"name":69,"class":70},"University of Oxford","OTHER",2,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":16,"sex":17,"minAge":48,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":52,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":71},"100574078","phase-1-a-study-to-evaluate-the-safety-tolerability-and-immunogenicity-of-a-recombinant-respiratory-syncytial-virus-vaccine-100574078","NCT06754605","A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Recombinant Respiratory Syncytial Virus Vaccine","A Randomized, Double-blind, Placebo-controlled Phase 1\u002F2 Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Recombinant Respiratory Syncytial Virus Vaccine (SCTV02) in Healthy Adults ≥18 Years of Age","Inclusion Criteria:\n\n* Phase I: male and female participants ≥18 years old at the time of signing the ICF; Phase II: male and female participants ≥50 years of age at the time of signing the ICF.\n* Be able to sign a written Informed consent form (ICF) and participate in the trial voluntarily, and can fully understand the trial procedures and risks of participating in the trial.\n* Be able to complete the diary card, contact card and diary\u002Fcontact card by own or with the assistance of others.\n* Phase I: healthy subjects or healthy subjects judged by the investigator according to the clinical data of the subjects; Stage II: Subjects who are healthy or have a stable underlying disease.\n* Fertile men and women of childbearing age voluntarily agree to use effective contraception from the time they sign the ICF until 6 months after immunization; Pregnancy test results for women of childbearing age during the screening period were negative.\n\nExclusion Criteria:\n\n* Acute illness and\u002For fever (axillary temperature ≥37.3 ° C) occurred within 3 days prior to vaccination with the study vaccine, or antipyretic, analgesic, or antiallergic drugs.\n* Use any investigational or unregistered product within 30 days prior to immunization, or plan to use any such product during the study period.\n* Concurrent participation in another clinical study where the subject has been or will be exposed to an investigational or non-investigational vaccine\u002Fproduct at any time during the study.\n* Long-term or high-dose glucocorticoid therapy (duration ≥15 days, or dose ≥1 mg\u002Fkg\u002F day of prednisone or equivalent doses of other glucocorticoids), or other immunosuppressive and cytotoxic therapy within 90 days prior to vaccination.\n* The study received a non-attenuated vaccine within 14 days prior to vaccination, or a live attenuated vaccine within 28 days; Have previously received the experimental respiratory syncytial virus (RSV) vaccine or been infected with RSV within 1 year prior to receiving the investigational vaccine.\n* History or family history of epilepsy and mental illness.\n* A family history of congenital or hereditary immunodeficiency, or a history and physical examination confirmed or suspected immunosuppression or immunodeficiency, or human immunodeficiency virus (HIV) infection, asplenia or functional asplenia.\n* Have the following organ-specific or systemic autoimmune diseases: Guillain-Barre syndrome, myasthenia gravis, autoimmune hepatitis, ulcerative colitis, systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, and systemic sclerosis.\n* Allergic to any component of the study vaccine, or any previous history of severe allergy to vaccine vaccination, such as anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis reaction, angioneurotic edema, etc.\n* Severe chronic disease or active chronic disease, as assessed by the investigator, including but not limited to myocardial infarction, severe arrhythmia, unstable angina, uncontrolled blood pressure after medication (systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg in subjects \\\u003C 60 years of age; Hypertensive disease with systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\> 100 mmHg in subjects ≥60 years of age, diabetes mellitus with serious complications, cancer or precancerous lesions, and other serious cerebrovascular diseases, heart diseases, respiratory diseases, liver and kidney diseases, and thyroid diseases.\n* Pregnant women (positive pregnancy test) or breastfeeding women, or those with pregnancy plans during the study period, or less than 6 weeks after the end of pregnancy (including ectopic pregnancy).\n\nPlan to donate eggs or sperm during the study.\n\n* Unable to follow the trial procedures, or plan to relocate or stay away for a long period of time during the study and cannot complete the trial follow-up.\n* Any medical condition that makes intramuscular injection unsafe due to other abnormalities, conditions that may obfuscate the results of the study, or conditions that are not in the best interest of the subject, is determined by the investigator to be unsuitable for clinical study.","120 Years",{"count":81,"type":22},480,[83,54],"PHASE1","This is a randomised, double-blind, placebo-controlled Phase 1\u002F2 clinical trial to evaluate the safety, tolerability and immunogenicity of recombinant respiratory syncytial virus in participants aged 18 years and older.",[26],"2025-02-11",{"date":88,"type":31},"2025-02-13",{"date":90,"type":31},"2025-02-06",{"date":92,"type":22},"2027-07-30",{"name":94,"class":38},"Sinocelltech Ltd."]