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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00090220 |
This study is to assess the tolerability and efficacy of a vaccine being evaluated to reduce the incidence of human papillomavirus (HPV) infection and disease (external genital warts and vulvar, vaginal, and cervical cancer) in women.
Condition | Intervention | Phase |
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Healthy Papillomavirus Infection |
Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine Biological: Comparator: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Safety, Immunogenicity, and Efficacy of Gardasil (V501 (Human Papilloma Virus [Types 6, 11, 16, 18] Recombinant Vaccine) in Mid-Adult Women - The FUTURE III (Females United to Unilaterally Reduce Endo/Ectocervical Cancer) Study |
Enrollment: | 3800 |
Study Start Date: | June 2004 |
Study Completion Date: | June 2009 |
Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Gardasil
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Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Gardasil intramuscular injection in three 0.5 mL doses over 6 months.
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2: Placebo Comparator
Placebo
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Biological: Comparator: Placebo
Placebo intramuscular injection in three 0.5 mL doses over 6 months.
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Ages Eligible for Study: | 24 Years to 45 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_013, V501-019 |
Study First Received: | August 25, 2004 |
Last Updated: | August 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00090220 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases DNA Virus Infections Papillomavirus Infections Healthy Papilloma |
Virus Diseases Tumor Virus Infections DNA Virus Infections Papillomavirus Infections Infection |