[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100247716":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":50,"centralContacts":37,"locations":37,"responsibleParty":54,"collaborators":37,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":37,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":37,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":37,"overallStatus":75,"whyStopped":37,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":37},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"V920 Consistency Lot A","EXPERIMENTAL","Participants received a 1.0 mL intramuscular injection of V920 on Day 1",[13],"Biological: V920 Consistency Lot A",{"label":15,"type":10,"description":11,"interventionNames":16},"V920 Consistency Lot B",[17],"Biological: V920 Consistency Lot B",{"label":19,"type":10,"description":11,"interventionNames":20},"V920 Consistency Lot C",[21],"Biological: V920 Consistency Lot C",{"label":23,"type":10,"description":11,"interventionNames":24},"V920 High-dose Lot",[25],"Biological: V920 High-dose Lot",{"label":27,"type":28,"description":29,"interventionNames":30},"Placebo to V920","PLACEBO_COMPARATOR","Participants received a 1.0 mL intramuscular injection of placebo on Day 1",[31],"Biological: Placebo to V920",[33,38,41,44,47],{"type":34,"name":9,"description":35,"armGroupLabels":36,"otherNames":37},"BIOLOGICAL","V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot A, live, attenuated, sterile solution for intramuscular injection",[9],null,{"type":34,"name":15,"description":39,"armGroupLabels":40,"otherNames":37},"V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot B, live, attenuated, sterile solution for intramuscular injection",[15],{"type":34,"name":19,"description":42,"armGroupLabels":43,"otherNames":37},"V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot C, live, attenuated, sterile solution for intramuscular injection",[19],{"type":34,"name":23,"description":45,"armGroupLabels":46,"otherNames":37},"V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine high-dose lot, live, attenuated, sterile solution for intramuscular injection",[23],{"type":34,"name":27,"description":48,"armGroupLabels":49,"otherNames":37},"Sodium chloride 0.9%, sterile solution for intramuscular injection",[27],[51],{"name":52,"affiliation":5,"role":53},"Medical Director","STUDY_DIRECTOR",{"type":55,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100247716","phase-3-evaluation-of-the-safety-and-immunogenicity-of-three-consistency-lots-and-a-high-dose-lot-of-rvsv-zebov-gp-v920-ebola-vaccine-in-healthy-adults-v920-012-100247716",true,"NCT02503202","Evaluation of the Safety and Immunogenicity of Three Consistency Lots and a High-Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults (V920-012)","A Phase III, Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Immunogenicity of Three Consistency Lots and a High Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults","Inclusion Criteria:\n\n* Not of reproductive potential, or of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner for 2 months following study vaccination.\n\nExclusion Criteria:\n\n* Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 90 days of participation in this trial.\n* Has previously been randomized in another clinical trial and received V920 or any other Ebola vaccine.\n* Has been exposed to Ebola virus at any time prior to study entry.\n* Is pregnant or breastfeeding or plans to conceive within 2 months following study vaccination.\n* Has direct household exposure to a pregnant or lactating woman at the time of participation in this trial.\n* Has had a fever (≥100.5ºF\u002F38.0ºC) within 48 hours prior to study entry.\n* Has received systemic corticosteroids (equivalent of ≥2 mg\u002Fkg total daily dose of prednisone or ≥20 mg\u002Fday for persons weighing \\>10 kg) for ≥14 consecutive days and has not completed treatment at least 30 days prior to study entry.\n* Has received systemic corticosteroids exceeding physiologic replacement doses (\\~5 mg\u002Fday prednisone equivalent) within 14 days prior to study entry.\n* Has received any live virus vaccine within 30 days prior to study entry or any other (nonlive virus) vaccine within 14 days prior to study entry.\n* Has known or suspected impairment of immunological function (e.g., HIV positive).\n* Has direct household exposure to a person with known or suspected impairment of immunological function (e.g., HIV positive).\n* Has a clinically significant history of intravenous (IV) drug abuse within 12 months prior to study entry.\n* Has a known allergy\u002Fsensitivity or contraindication to investigational product(s) or its\u002Ftheir excipients (e.g., albumin).\n* Has a history of malignancy \\\u003C=5 years prior to study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n* Is or has an immediate family member (e.g., spouse, parent\u002Flegal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.","ALL","18 Years","65 Years",{"count":67,"type":68},1197,"ACTUAL","INTERVENTIONAL",[71],"PHASE3","The study evaluated the safety and immunogenicity of 3 consistency lots and a high-dose lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in healthy adults. The primary purpose of this study was to demonstrate consistency in the immune responses of participants receiving 3 separate lots of V920 through 28 days postvaccination. In addition to the 3 lot groups, a high-dose group and a placebo group were studied. A subset of participants representative of all treatment groups continued through 24 months postvaccination in the extension study for the evaluation of long-term safety. The primary hypothesis states that the geometric mean titer of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibody at 28 days postvaccination is equivalent across the three consistency lots.",[74],"Prevention of Ebola Infection","COMPLETED","2018-10-09",{"date":78,"type":68},"2018-10-12",{"date":80,"type":68},"2015-08-17",{"date":82,"type":68},"2017-09-29",{"name":5,"class":6}]