[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100086203":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":20,"locations":20,"responsibleParty":25,"collaborators":20,"id":27,"slug":28,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":32,"acronym":20,"eligibilityCriteria":33,"healthyVolunteers":29,"sex":34,"minAge":35,"maxAge":36,"enrollmentInfo":37,"targetDuration":20,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":20,"overallStatus":46,"whyStopped":20,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":20},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)","EXPERIMENTAL","Participants who enroll receive a total of 3 intramuscular injections of Quadrivalent HPV VLP vaccine (types 6, 11, 16, 18) given on Day 1, Month 2 and Month 6.",[13],"Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine","Quadrivalent HPV vaccine (6, 11, 16, 18) given intramuscularly on Day 1, Month 2, and Month 6.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Medical Director","STUDY_DIRECTOR",{"type":26,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100086203","phase-3-safety-tolerability-and-immunogenicity-of-hpv-human-papilloma-virus-vaccine-in-healthy-females-9-to-15-years-of-age-in-india-v501-029-100086203",true,"NCT00380367","Safety, Tolerability and Immunogenicity of HPV (Human Papilloma Virus) Vaccine in Healthy Females 9 to 15 Years of Age in India (V501-029)","Evaluation of Safety, Tolerability and Immunogenicity of Quadrivalent HPV Vaccine in Healthy Females 9 to 15 Years of Age in India","Inclusion Criteria:\n\n* Healthy Females Age 9 To 15 Years\n* Females Not Sexually Active And Not Plan On Becoming Sexually Active During The Study\n* No Fevers 24 Hours Prior To The First Injection\n\nExclusion Criteria:\n\n* Participant Had Received A Prior Vaccination With A HPV Vaccine\n* Participant Has Allergies To Vaccine Component Including Aluminum And Yeast\n* Participant Has (Human Immunodeficiency Virus) HIV Infection\n* Participant Is Immunocompromised\n* Participant Received Or Plans To Receive Blood-Derived Product Within 6 Months Prior To The First Injection\n* Participant Received Or Plans To Receive Immune Globulin Preparation Within 6 Months To The First Injection","FEMALE","9 Years","15 Years",{"count":38,"type":39},110,"ACTUAL","INTERVENTIONAL",[42],"PHASE3","The purpose of this study is to evaluate the safety and tolerability of the Quadrivalent Human Papilloma Virus (HPV) vaccine in healthy females 9 to 15 years of age in India. Quadrivalent HPV Vaccine is composed of L1 virus-like particles (VLPs) from HPV types 6, 11, 16, and 18.",[45],"Papillomavirus Infections","COMPLETED","2023-05-02",{"date":49,"type":39},"2023-05-31",{"date":51,"type":39},"2007-05-03",{"date":53,"type":39},"2008-02-04",{"name":5,"class":6}]