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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00090285 |
This study is to evaluate an investigational vaccine with the following objectives: To demonstrate that the vaccine is well-tolerated in young men; To demonstrate that the vaccine reduces incidence of Condylomata Acuminata (anogenital warts) in young men; and To demonstrate that the vaccine reduces incidence of human papillomavirus (HPV) infection in young men.
Condition | Intervention | Phase |
---|---|---|
Condylomata Acuminata |
Biological: (Gardasil) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine Biological: Comparator: placebo (unspecified) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | An Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men |
Estimated Enrollment: | 2700 |
Study Start Date: | September 2004 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Biological: (Gardasil) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Duration of Treatment: 6 months
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2: Placebo Comparator |
Biological: Comparator: placebo (unspecified)
Duration of Treatment: 6 months
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Ages Eligible for Study: | 16 Years to 26 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2004_103, Formerly-0904HPVHMES, V501-020 |
Study First Received: | August 25, 2004 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00090285 |
Health Authority: | United States: Food and Drug Administration |
anogenital warts |
Virus Diseases Skin Diseases, Infectious Sexually Transmitted Diseases, Viral Warts Skin Diseases Condyloma acuminatum |
Condylomata Acuminata Sexually Transmitted Diseases Condyloma DNA Virus Infections Papillomavirus Infections |
Skin Diseases, Viral Tumor Virus Infections |