[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100399854":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":34,"responsibleParty":47,"collaborators":10,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":10,"maxAge":10,"enrollmentInfo":59,"targetDuration":62,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":10,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},{"fullName":5,"class":6},"Sanofi","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Pregnant women and their offspring(s)",null,"Women and their offspring(s) exposed to Dengvaxia during pregnancy",[13],"Biological: Dengue Tetravalent Vaccine, Live",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"BIOLOGICAL","Dengue Tetravalent Vaccine, Live","Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Subcutaneous",[9],[21],{"name":22,"affiliation":5,"role":23},"Clinical Sciences & Operations","STUDY_DIRECTOR",[25,29],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":10},"Dengvaxia US Pregnancy Registry HelpLine","CONTACT","1-800-822-2463",{"name":30,"role":27,"phone":31,"phoneExt":32,"email":33},"Trial Transparency email recommended (Toll free number for US & Canada)","800-633-1610","option 6","contact-us@sanofi.com",[35],{"facility":36,"status":37,"city":38,"state":10,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":10},"Investigational Site","RECRUITING","San Juan","Puerto Rico","PR",{"type":42,"coordinates":43},"Point",[44,45],-66.10572,18.46633,{"lat":45,"lon":44},{"type":48,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100399854","dengvaxia-us-pregnancy-registry-100399854",false,"NCT04486638","Dengvaxia US Pregnancy Registry","Dengvaxia US Pregnancy Registry: A Surveillance Study to Assess the Safety of Dengvaxia Among Exposed Pregnant Women and Their Offsprings (DNG00044)","DNG00044","The eligible population will include pregnant women of any age and their offspring(s) residing in the US and its Territories whose Dengvaxia pregnancy exposure is reported to the pregnancy registry.\n\nReports of Dengvaxia pregnancy exposure must contain the following information to be included in the registry:\n\n* Sufficient evidence to confirm the case qualifies as \"exposed during pregnancy\";\n* Vaccine name (brand or generic) is provided (i.e., including manufacturer unknown exposures).\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",true,"ALL",{"count":60,"type":61},500,"ESTIMATED","22 Months","OBSERVATIONAL","The primary objective of this study is to assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women and their offspring(s) vaccinated with Dengvaxia during their pregnancy",[66],"Dengue Virus Infection","2026-01-19",{"date":69,"type":70},"2026-01-21","ACTUAL",{"date":72,"type":70},"2023-01-01",{"date":74,"type":61},"2029-06-30",{"name":76,"class":6},"Sanofi Pasteur, a Sanofi Company",1]