[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100399854":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":33,"studyPopulation":34,"armGroups":35,"interventions":41,"overallOfficials":47,"centralContacts":51,"locations":61,"responsibleParty":74,"collaborators":29,"id":76,"slug":29,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":29,"maxAge":29,"enrollmentInfo":85,"targetDuration":88,"studyType":89,"phases":29,"briefSummary":90,"conditions":91,"keywords":29,"overallStatus":64,"whyStopped":29,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},{"fullName":5,"class":6},"Sanofi","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":29,"otherOutcomes":29},[9,13,17,21,25],{"measure":10,"description":11,"timeFrame":12},"Percentage of pregnant women with maternal adverse events","Maternal adverse events are reported as serious or non-serious","From vaccination until end of follow-up (maximum 22 months after cohort entry)",{"measure":14,"description":15,"timeFrame":16},"Pecentage of women with obstetrical adverse events","Obstetrical adverse events are collected during pregnancy, labour, delivery and puerperium, and are reported as serious or non-serious","From vaccination until 1 month post-delivery",{"measure":18,"description":19,"timeFrame":20},"Percentage of participants with adverse pregnancy outcome","Adverse pregnancy outcomes include ectopic pregnancy, elective\u002Finduced abortion with no fetal defect(s) or fetus status unknown, elective\u002Finduced abortion with fetal defect(s), spontaneous abortion\u002Fmiscarriage (\\\u003C20 weeks), stillbirth\u002Ffetal death at 20-27 weeks, fetal death at ≥28 weeks, and fetal death due to maternal death","On day of birth",{"measure":22,"description":23,"timeFrame":24},"Percentage of offsprings with neonatal adverse events","Neonatal events are reported as serious or non-serious","From day of birth to 28 days post-birth",{"measure":26,"description":27,"timeFrame":28},"Percentage of offsprings with infant adverse events","Infant events are reported as serious or non-serious","From 29 days to 365 days post-birth",null,{"allocation":29,"interventionModel":29,"interventionModelDescription":29,"primaryPurpose":29,"observationalModel":31,"timePerspective":32,"maskingInfo":29},"COHORT","PROSPECTIVE","Exposed pregnant women will be followed up to the end of their pregnancy, and the offspring(s) will be followed up to 1 year of age.","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",[36],{"label":37,"type":29,"description":38,"interventionNames":39},"Pregnant women and their offspring(s)","Women and their offspring(s) exposed to Dengvaxia during pregnancy",[40],"Biological: Dengue Tetravalent Vaccine, Live",[42],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":29},"BIOLOGICAL","Dengue Tetravalent Vaccine, Live","Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Subcutaneous",[37],[48],{"name":49,"affiliation":5,"role":50},"Clinical Sciences & Operations","STUDY_DIRECTOR",[52,56],{"name":53,"role":54,"phone":55,"phoneExt":29,"email":29},"Dengvaxia US Pregnancy Registry HelpLine","CONTACT","1-800-822-2463",{"name":57,"role":54,"phone":58,"phoneExt":59,"email":60},"Trial Transparency email recommended (Toll free number for US & Canada)","800-633-1610","option 6","contact-us@sanofi.com",[62],{"facility":63,"status":64,"city":65,"state":29,"zip":29,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":29},"Investigational Site","RECRUITING","San Juan","Puerto Rico","PR",{"type":69,"coordinates":70},"Point",[71,72],-66.10572,18.46633,{"lat":72,"lon":71},{"type":75,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","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":86,"type":87},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",[92],"Dengue Virus Infection","2026-01-19",{"date":95,"type":96},"2026-01-21","ACTUAL",{"date":98,"type":96},"2023-01-01",{"date":100,"type":87},"2029-06-30",{"name":102,"class":6},"Sanofi Pasteur, a Sanofi Company",1]