[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529352":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":30,"centralContacts":34,"locations":39,"responsibleParty":57,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":10,"eligibilityCriteria":68,"healthyVolunteers":65,"sex":69,"minAge":10,"maxAge":70,"enrollmentInfo":71,"targetDuration":10,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":10,"overallStatus":42,"whyStopped":10,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Yale University","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"ARI Cases",null,"Cases will be defined as infants ≤12 months old who had a clinical encounter for acute respiratory illness (ARI) and tested positive for RSV using polymerase chain reaction (PCR).",[13],"Drug: Nirsevimab",{"label":15,"type":10,"description":16,"interventionNames":17},"Healthy Controls","Healthy controls will be individually matched to enrolled vaccine failures (immunized and RSV+) by date of birth (±1 month), sex, and immunoprophylactic agent received (i.e., maternal vaccine or monoclonal antibody).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"ARI Controls","Controls will be individuals with ARI who test negative for RSV and will be frequency matched based on time and clinical setting.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Nirsevimab","Immunoprophylaxis against RSV",[9,19,15],[29],"RSV vaccines",[31],{"name":32,"affiliation":5,"role":33},"Carlos R Oliveira, MD","PRINCIPAL_INVESTIGATOR",[35],{"name":32,"role":36,"phone":37,"phoneExt":10,"email":38},"CONTACT","203-785-5474","carlos.oliveira@yale.edu",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Yale Child Health Research Center","RECRUITING","New Haven","Connecticut","06519","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-72.92816,41.30815,{"lat":52,"lon":51},[55],{"name":56,"role":36,"phone":37,"phoneExt":10,"email":10},"Research Coordinator",{"type":58,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[60],{"name":61,"class":62},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH","100529352","real-world-effectiveness-of-perinatal-rsv-immunoprophylaxis-100529352",false,"NCT06172660","Real-World Effectiveness of Perinatal RSV Immunoprophylaxis","Inclusion Criteria:\n\n* ≤ 12 months of age at the time of presentation for evaluation for an acute respiratory infection (ARI).\n* Documentation of an ARI, which is defined as an acute onset (\\\u003C10 days) illness that includes: At least two of the following symptoms: fever (measured or subjective), chills, rigors, myalgia, headache, sore throat, nausea or vomiting, diarrhea, fatigue, congestion OR any one of the following: cough, shortness of breath, difficulty breathing, olfactory disorder, taste disorder, confusion, persistent chest pain, pale, gray, hypoxia, clinical or radiographic evidence of pneumonia or respiratory distress syndrome.\n* Residents of Connecticut\n\nExclusion Criteria:\n\n* Illness duration of \\>10 days at the time of respiratory specimen collection, measured from the date of the first symptom of the current acute illness.\n* Parents\u002Fguardians are not able to provide informed consent\n\nTo be eligible for inclusion in the study as a healthy control, an individual must meet all of the following criteria:\n\n* Immunized against RSV ≤ 12 months of age\n* Residents of Connecticut\n* Match an enrolled case that was a vaccine failure by date of birth (±1 month), sex, and immunoprophylactic agent received (i.e., maternal vaccine vs mAb).","ALL","12 Months",{"count":72,"type":73},3750,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to continue evaluating how well the RSV vaccines work as they are currently being used in routine clinical practice. Some of the questions that the investigators hope to answer with this study are: 1) What is the overall effectiveness of these vaccines? 2) How long does immunity last? 3) How effective are the vaccines against new strains? 3) Does the vaccine's effectiveness vary by age?",[77],"RSV Infection","2025-08-08",{"date":80,"type":81},"2025-08-14","ACTUAL",{"date":83,"type":81},"2024-10-28",{"date":85,"type":73},"2028-12-30",{"name":5,"class":6},1]