[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100085068":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":32,"locations":32,"responsibleParty":37,"collaborators":32,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":32,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":32,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":32,"overallStatus":58,"whyStopped":32,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":32},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"1","EXPERIMENTAL","HPV 16 L1 VLP vaccine",[13],"Biological: Comparator: HPV 16 L1 Vaccine",{"label":15,"type":16,"description":17,"interventionNames":18},"2","PLACEBO_COMPARATOR","Placebo",[19],"Biological: Comparator: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Comparator: HPV 16 L1 Vaccine","A 0.5 intramuscular injection given at Day 1, Month 2, and Month 6",[9],[27],"V501",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Comparator: Placebo","A 0.5 intramuscular placebo injection given at Day 1, Month 2, and Month 6",[15],null,[34],{"name":35,"affiliation":5,"role":36},"Medical Monitor","STUDY_DIRECTOR",{"type":38,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100085068","phase-2-study-of-human-papillomavirus-hpv-16-vaccine-in-the-prevention-of-hpv-16-infection-in-16--to-23-year-old-females-v501-005-100085068",true,"NCT00365378","Study of Human Papillomavirus (HPV) 16 Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females (V501-005)","Study of Pilot Manufacturing Lot of HPV 16 Virus-Like Particle (VLP) Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females","Inclusion Criteria:\n\n* Healthy, unmarried females age 16 to 23 years with intact uteri\n* Not pregnant at enrollment\n* Agreed to use effective contraception through Month 7 of the study\n* A lifetime history of 0 to 5 male partners with whom the subjects engaged in at least one episode of insertive intercourse\n\nExclusion Criteria:\n\n* No prior history of Human Papillomavirus (HPV) vaccination\n* No receipt of any other vaccination within 1 month prior to enrollment or plans to receive any other vaccination within 1 month prior to or after any dose of study vaccine\n* No prior history of an abnormal Papanicolaou (Pap) test showing Squamous intraepithelial lesion (SIL) or biopsy showing Cervical intraepithelial neoplasia (CIN)","FEMALE","16 Years","23 Years",{"count":50,"type":51},2409,"ACTUAL","INTERVENTIONAL",[54],"PHASE2","Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy, immunogenicity, and safety.",[57],"HPV 16 Infection","COMPLETED","2015-10-22",{"date":61,"type":62},"2015-10-23","ESTIMATED",{"date":64,"type":32},"1999-09",{"date":66,"type":51},"2009-07",{"name":5,"class":6}]