August 25, 2004 |
October 31, 2008 |
September 2004 |
Incidence of HPV related external genital warts, PIN, penile, perianal or perineal cancer. [ Time Frame: Duration of Treatment ] [ Designated as safety issue: No ] |
Same as current |
Complete list of historical versions of study NCT00090285 on ClinicalTrials.gov Archive Site |
Persistent HPV 6, 11, 16, and 18 infection.; HPV 6, 11, 16, and 18 detection. [ Time Frame: Duration of Treatment ] [ Designated as safety issue: No ] |
- Reduction in the incidence of persistent HPV 6, 11, 16, and 18 infection.
- Reduction in the incidence of HPV 6, 11, 16, and 18 detection at one or more visits
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An Investigational Study of Gardasil (V501) in Reducing the Incidence of Anogenital Warts in Young Men |
An Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men |
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. |
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Phase III |
Interventional |
Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Condylomata Acuminata |
- Biological: (Gardasil) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
- Biological: Comparator: placebo (unspecified)
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Active, not recruiting |
2700 |
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May 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Healthy males between the ages of 16 and 26
- No known history of genital warts
- Additional criteria will be discussed with you by the physician
Exclusion Criteria:
- Female
- Cannot have a history of known prior vaccination with an HPV
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Male |
16 Years to 26 Years |
Yes |
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NCT00090285 |
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
Formerly-0904HPVHMES, V501-020 |
Merck |
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Study Director: |
Medical Monitor |
Merck |
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Merck |
October 2008 |