[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643183":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":31,"responsibleParty":43,"collaborators":10,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":10,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":52,"minAge":53,"maxAge":10,"enrollmentInfo":54,"targetDuration":10,"studyType":57,"phases":10,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":64,"whyStopped":10,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Sanofi","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1",null,"\"Catch-up cohort\", i.e. all infants born between April and September in Czechia.",[13],"Biological: Nirsevimab Respiratory Syncytial Virus monoclonal antibody",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","\"In-season cohort\", i.e. all infants born during the RSV season between October and March in Czechia.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"BIOLOGICAL","Nirsevimab Respiratory Syncytial Virus monoclonal antibody","This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice",[9,15],[25],{"name":26,"role":27,"phone":28,"phoneExt":29,"email":30},"Trial Transparency email recommended (Toll free for US & Canada)","CONTACT","800-633-1610","option 6","Contact-US@sanofi.com",[32],{"facility":33,"status":10,"city":34,"state":10,"zip":35,"country":36,"countryCode":10,"cosmosGeoPoint":37,"geoPoint":42,"contacts":10},"Sanofi s.r.o.","Prague","160 00","Czechia",{"type":38,"coordinates":39},"Point",[40,41],14.42076,50.08804,{"lat":41,"lon":40},{"type":44,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100643183","an-observational-study-to-assess-nirsevimab-immunization-rates-in-eligible-infants-during-their-first-rsv-season-in-the-czechia-100643183",false,"NCT07634692","An Observational Study to Assess Nirsevimab Immunization Rates in Eligible Infants During Their First RSV Season in the Czechia","Inclusion Criteria:\n\n* Be a parent of an infant born between April 2025\u002F26 and March 2026\u002F27, respectively\n* Permanent residence in Czechia at the time of survey completion and speak Czech\n* Be at least 18 years old at the time of survey completion\n* Agree with privacy policy and AE (Adverse Event) reporting requirements before proceeding with the survey\n* Read and agree to the ICF (Informed Consent Form) by ticking a box before proceeding with the survey\n\nExclusion criteria:\n\n* N\u002FA\n\nThe above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.",true,"ALL","18 Years",{"count":55,"type":56},250,"ESTIMATED","OBSERVATIONAL","The primary objective of this study is to determine the nirsevimab immunization rate in eligible infants in their first RSV-season in Czechia.\n\nThe study will focus on:\n\n1. Assessing nirsevimab immunization rates among eligible infants (according to ČVS recommendation) in their first RSV-season in Czechia (i.e. across all geographies)\n2. Assessing nirsevimab immunisation rates among the \"catch-up cohort\", i.e. all infants born between April and September.\n3. Assessing nirsevimab immunization rate among the \"in-season cohort\", i.e. all infants born during the RSV season between October and March.\n\nSecondary objectives are:\n\n1. To analyze reasons of parents to decide for or against immunization of their infant with nirsevimab.\n2. To assess immunization rates for further subgroups, if sufficient sample for subgroup achieved, e.g. by: risk group (defined chronic condition or pre-term birth status)\n3. To assess concordance of a parent survey results based on randomly sampled parent population using Computer-Assisted Self-Interviewing (CASI) for estimating immunization rates in Czechia with coverage calculated based on pharmacy sales data.",[60],"RSV Immunization",[62,63],"nirsevimab;","nirsevimab immunization rates","NOT_YET_RECRUITING","2026-06-03",{"date":67,"type":68},"2026-06-09","ACTUAL",{"date":70,"type":56},"2026-06-15",{"date":72,"type":56},"2026-07-17",{"name":5,"class":6},1]