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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00092521 |
The primary purpose of the study is to determine if Gardasil (V501) with four components is able to prevent cervical cancer, cervical dysplasia, and genital warts.
Condition | Intervention | Phase |
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Cervical Cancer Genital Warts |
Biological: V501, Gardasil, human papillomavirus (types 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Study to Evaluate the Efficacy of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, and 18) L1 Virus-Like Particle (VLP) Vaccine in Reducing the Incidence of HPV 6/11-, 16-, and 18-Related CIN and VaIN, and HPV 6/11-, 16-, and 18-Related External Genital Warts and VI |
Estimated Enrollment: | 5700 |
Study Start Date: | December 2001 |
Study Completion Date: | July 2007 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 16 Years to 23 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2004_081, V501-013 |
Study First Received: | September 23, 2004 |
Last Updated: | July 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00092521 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Sexually Transmitted Diseases, Viral Skin Diseases Condyloma Acuminatum Condyloma Cervical Intraepithelial Neoplasia Carcinoma Virus Diseases Skin Diseases, Infectious |
Warts Condylomata Acuminata Carcinoma in Situ Sexually Transmitted Diseases Papillomavirus Infections DNA Virus Infections Neoplasms, Glandular and Epithelial |
Sexually Transmitted Diseases, Viral Neoplasms by Histologic Type Skin Diseases Tumor Virus Infections Carcinoma Cervical Intraepithelial Neoplasia Virus Diseases Skin Diseases, Viral Neoplasms |
Skin Diseases, Infectious Warts Condylomata Acuminata Carcinoma in Situ Sexually Transmitted Diseases Papillomavirus Infections DNA Virus Infections Neoplasms, Glandular and Epithelial |