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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00517309 |
The primary purpose of the study is to test the safety of HPV Vaccine in Women
Condition | Intervention | Phase |
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Cervical Cancer Genital Warts |
Biological: V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years Biological: Comparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 Years |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Immunogenicity and Safety of Quadrivalent HPV L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women When Administered Alone or Concomitantly With Hepatitis B Vaccine (Recombinant)--the F.U.T.U.R.E. Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease |
Estimated Enrollment: | 1800 |
Study Start Date: | March 2003 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (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: | 2007_576, V501-011 |
Study First Received: | August 15, 2007 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00517309 |
Health Authority: | United States: Food and Drug Administration |
Sexually Transmitted Diseases, Viral Liver Diseases Skin Diseases Condyloma Hepatitis, Viral, Human Hepatitis Virus Diseases Skin Diseases, Infectious |
Digestive System Diseases Warts Condyloma acuminatum Condylomata Acuminata Sexually Transmitted Diseases Hepatitis B Papillomavirus Infections DNA Virus Infections |
Skin Diseases, Viral Tumor Virus Infections Hepadnaviridae Infections |