[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608334":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":22,"locations":29,"responsibleParty":36,"collaborators":10,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":10,"eligibilityCriteria":44,"healthyVolunteers":45,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":10,"studyType":52,"phases":10,"briefSummary":53,"conditions":54,"keywords":10,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},{"fullName":5,"class":6},"Sanofi","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1",null,"Children up to 24 months of age who are scheduled to receive Beyfortus according to the approved indications will be selected as participants under the real-world clinical practice settings during the surveillance period.",[13],"Biological: Nirsevimab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Nirsevimab","Route of Administration: Intramuscular Pharmaceutical Form: Solution for injection",[9],[21],"Beyfortus™",[23],{"name":24,"role":25,"phone":26,"phoneExt":27,"email":28},"Trial Transparency email recommended (Toll free for US & Canada)","CONTACT","800-633-1610","option 6","Contact-US@sanofi.com",[30],{"facility":31,"status":32,"city":33,"state":10,"zip":34,"country":35,"countryCode":10,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"Nam Seung Woo Pediatric: 4100007","RECRUITING","Hwaseong-si, Gyeonggi-do","18478","South Korea",{"type":37,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","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":50,"type":51},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.",[55],"Respiratory Syncytial Virus","2025-11-25",{"date":58,"type":59},"2025-12-03","ACTUAL",{"date":61,"type":59},"2025-10-02",{"date":63,"type":51},"2029-09-26",{"name":5,"class":6},1]