[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100427215":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":33,"responsibleParty":48,"collaborators":10,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":10,"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":36,"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,"Pregnant women and their offspring(s) exposed to MenQuadfi® during their pregnancy or within 30 days prior to their LMP",[13],"Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine","Pharmaceutical form: Solution for injection Route of administration: Intramuscular",[9],[21],"Meningococcal A-C-Y-W135 (T CONJ) vaccine",[23],{"name":24,"affiliation":5,"role":25},"Clinical Sciences & Operations","STUDY_DIRECTOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Trial Transparency email recommended (Toll free number for US & Canada)","CONTACT","800-633-1610","option 6","Contact-Us@sanofi.com",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":10},"Pennsylvania Locations","RECRUITING","Swiftwater","Pennsylvania","18370-0187","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-75.32491,41.09537,{"lat":46,"lon":45},{"type":49,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100427215","observational-passive-surveillance-program-to-collect-information-on-women-and-their-offspring-exposed-to-menquadfi-during-pregnancy-in-united-states-us-100427215",false,"NCT04843111","Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)","The MenQuadfi® Pregnancy Registry: A Surveillance Registry to Assess the Safety of MenQuadfi® Among Exposed Pregnant Women and Their Offspring","Inclusion Criteria:\n\nThe eligible population will include pregnant women and their offspring residing in the US and its territories who are exposed to MenQuadfi® during their pregnancy or within 30 days prior to their LMP, for whom the exposure is reported to the pregnancy registry.\n\nReports of MenQuadfi® pregnancy exposure must contain the following information:\n\n* Sufficient evidence to confirm that vaccination occurred during the pregnancy or in the 30 days preceding the LMP;\n* Vaccine name (brand or generic) is provided (i.e., MenQuadfi®, Meningococcal vaccine, MenACWY conjugate vaccine), or not specified (eg, meningococcal vaccine from an unknown manufacturer).\n\nExclusion Criteria:\n\nOnly post-marketing spontaneous case reports will be included; reports from clinical trials will not be part of the registry.\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},50,"ESTIMATED","22 Months","OBSERVATIONAL","Primary Objective:\n\nTo assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women vaccinated with MenQuadfi® during pregnancy or in the 30 days preceding their Last Menstrual Period (LMP).",[66],"Meningococcal Infection","2025-11-27",{"date":69,"type":70},"2025-12-01","ACTUAL",{"date":72,"type":70},"2021-03-05",{"date":74,"type":61},"2028-05-18",{"name":76,"class":6},"Sanofi Pasteur, a Sanofi Company",1]