[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100405219":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":26,"locations":35,"responsibleParty":54,"collaborators":56,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":26,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":26,"overallStatus":84,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Janssen Vaccines & Prevention B.V.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: Ad26.ZEBOV, MVA-BN-Filo","EXPERIMENTAL","Participants will receive intramuscular (IM) injection (0.5 milliliter \\[mL\\]) of Adenovirus serotype 26 encoding the ebola virus mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 (5\\*10\\^10 viral particle(s) \\[vp\\]) on Day 1, followed by modified vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) as Dose 2 (1\\*10\\^8 infectious unit(s) \\[Inf U\\]) on Day 57.",[13,14],"Biological: Ad26.ZEBOV","Biological: MVA-BN-Filo",{"label":16,"type":17,"description":18,"interventionNames":19},"Group B: No vaccination during pregnancy","OTHER","Participants (pregnant women) in control Group B will not receive any vaccination during pregnancy. However, women in this group will receive the 2-dose vaccination regimen at the earliest 6 weeks after delivery\u002Ftermination of pregnancy that is Dose 1 of Ad26.ZEBOV vaccine (0.5 mL) (5\\*10\\^10 vp) on Day 1 by IM injection followed by 0.5 mL of MVA-BN-Filo (1\\*10\\^8 Inf U) vaccine by IM injection 56 days after Dose 1.",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Ad26.ZEBOV","Participants in Group A will receive 0.5 mL IM injection of Ad26.ZEBOV vaccine. Participants in Group B will receive Ad26.ZEBOV 6 weeks after delivery\u002Ftermination of pregnancy.",[9,16],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"MVA-BN-Filo","Participants in Group A will receive 0.5 mL IM injection of MVA-BN-Filo vaccine. Participants in Group B will receive MVA-BN-Filo 6 weeks after delivery\u002Ftermination of pregnancy.",[9,16],[32],{"name":33,"affiliation":5,"role":34},"Janssen Vaccines & Prevention B.V. Clinical Trial","STUDY_DIRECTOR",[36,41,44],{"facility":37,"status":26,"city":38,"state":26,"zip":26,"country":39,"countryCode":40,"cosmosGeoPoint":26,"geoPoint":26,"contacts":26},"Gihundwe District Hospital","Cuangugu","Rwanda","RW",{"facility":42,"status":26,"city":43,"state":26,"zip":26,"country":39,"countryCode":40,"cosmosGeoPoint":26,"geoPoint":26,"contacts":26},"Gisenyi Hospital","Gysenyi",{"facility":45,"status":26,"city":46,"state":26,"zip":47,"country":39,"countryCode":40,"cosmosGeoPoint":48,"geoPoint":53,"contacts":26},"Center for Family Health Research\u002FProject San Francisco","Kigali","780",{"type":49,"coordinates":50},"Point",[51,52],30.05885,-1.94995,{"lat":52,"lon":51},{"type":55,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[57,60,62],{"name":58,"class":59},"Center for Family Health Research (CFHR)","UNKNOWN",{"name":61,"class":17},"Coalition for Epidemic Preparedness Innovations",{"name":63,"class":17},"Emory University","100405219","phase-3-a-study-of-a-2-dose-ebola-vaccine-regimen-of-ad26zebov-followed-by-mva-bn-filo-in-healthy-pregnant-women-100405219",false,"NCT04556526","A Study of a 2-dose Ebola Vaccine Regimen of Ad26.ZEBOV Followed by MVA-BN-Filo in Healthy Pregnant Women","A Phase 3 Open-label Randomized Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of a 2-dose Ebola Vaccine Regimen of Ad26.ZEBOV Followed by MVA-BN-Filo in Healthy Pregnant Women","INGABO","Inclusion Criteria:\n\n* Healthy on the basis of physical examination, medical history, obstetric history, and vital signs performed at screening\n* Healthy on the basis of clinical laboratory tests performed at screening\n* Confirmed singleton pregnancy by positive urine human chorionic gonadotropin (HCG) and ultrasound at time of screening and informed consent, and reconfirmed pregnancy via ultrasound at Randomization\u002FDay 1\n* Residing within catchment area of the study site\n* Evidence of normal progress of gestation prior to Randomization (Day 1) based on obstetric evaluation (including obstetric history, obstetric examination and fetal ultrasound)\n\nExclusion Criteria:\n\n* History of Ebola Virus Disease (EVD) (self-declared or laboratory confirmed)\n* Has received any experimental candidate Ad26- or MVA-based vaccine in the past\n* Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the study vaccines \\[for example, polysorbate 80, ethylenediaminetetraacetic acid (EDTA) or L-histidine for Ad26.ZEBOV vaccine; tris (hydroxymethyl)-amino methane (THAM) for MVA-BN-Filo vaccine\\]), including known allergy to egg, egg products, chicken proteins and aminoglycosides\n* Participant with acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or body temperature greater than or equal to (\\>=)38.0ºC on Day 1 will be excluded from enrollment at that time but may be rescheduled for enrollment at a later date\n* During the 6 weeks prior to screening, have had any of (a) confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (COVID-19) infection (test positive), OR (b) suspected SARS-CoV-2 infection (clinical features without documented test results), OR (c) close contact with a person with known or suspected SARS-CoV-2 infection\n* Obstetric history including: a. \\>= 2 consecutive spontaneous abortions, b. history of pre-eclampsia or eclampsia, c. rhesus negative multigravida, d. grand multigravida (greater than \\[\\>\\] 5 previous pregnancies, e. previous late still birth (defined as loss of pregnancy at any time after 28 weeks gestation), f. previous low birth weight baby or premature delivery (defined as a delivery before 37 weeks gestation), g. previous neonatal death (defined as death of an infant within the first 28 days of life), h. previous delivery of an infant with a known or suspected genetic or chromosomal abnormality, i. history of other significant pregnancy-related or neonatal complications judged likely to affect the safety of the mother or infant or to significantly compromise the endpoint data collected",true,"FEMALE","18 Years",{"count":76,"type":77},4031,"ACTUAL","INTERVENTIONAL",[80],"PHASE3","The purpose of this study is: a) to assess adverse maternal\u002Ffetal outcomes in pregnant women randomized to receive the 2- dose Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo \\[Group A\\]) and in control women (unvaccinated pregnant women \\[Group B\\]); and b) to assess adverse neonatal\u002Finfant outcomes in neonates\u002Finfants born to women randomized to receive the 2-dose Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo \\[Group A\\]) and in neonates\u002Finfants born to control women (unvaccinated during pregnancy \\[Group B\\]).",[83],"Healthy","COMPLETED","2025-01-31",{"date":87,"type":77},"2025-02-03",{"date":89,"type":77},"2020-10-05",{"date":91,"type":77},"2023-03-02",{"name":5,"class":6},3]