Trials / Completed
CompletedNCT00090285
An Investigational Study of Gardasil™ (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)
An Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 4,065 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- Male
- Age
- 16 Years – 26 Years
- Healthy volunteers
- Accepted
Summary
This study was conducted to demonstrate that Gardasil™ (quadrivalent human papillomavirus \[qHPV\] vaccine) 1) is well tolerated in young men, 2) reduces incidence of external genital lesions in young men, 3) reduces the incidence of anal intraepithelial neoplasia (AIN) or anal cancer in men having sex with men (MSM), and 4) reduces incidence of Human Papillomavirus (HPV) infection in young men. In the 7-month Base Study participants received randomly assigned qHPV vaccine or placebo at Day 1, Month 2, and Month 6. Base Study follow-up continued through Month 36. In Extension 1 (EXT1), participants who received placebo or an incomplete qHPV vaccine regimen in the Base Study were offered qHPV vaccine. Participants were followed in EXT1 for 7 months. In Extension 2 \[LTFU (EXT2)\], long-term effectiveness, immunogenicity, and safety of qHPV vaccine were followed up to 10 years following study enrollment. Participants who received ≥1 dose of qHPV vaccine in the Base Study or EXT1 were eligible to enroll in LTFU (EXT2).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine | 0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study |
| BIOLOGICAL | Comparator: placebo (unspecified) | 0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study |
Timeline
- Start date
- 2004-09-03
- Primary completion
- 2009-07-31
- Completion
- 2017-04-03
- First posted
- 2004-08-27
- Last updated
- 2018-08-23
- Results posted
- 2009-11-19
Source: ClinicalTrials.gov record NCT00090285. Inclusion in this directory is not an endorsement.