At a glance
ClinicalIndex Comparison Record- ✓Heterosexual males aged 16–23 years 364 days, or men who have sex with men (MSM) aged 16–26 years 364 days
- ✓No clinical evidence of genital lesions suggesting sexually transmitted disease
- ✓No history of anogenital warts
- ✕Prior HPV vaccination
- ✕Inactivated vaccine within 14 days or live vaccine within 21 days prior to enrollment
- ✕Immune globulin or blood-derived products within 6 months prior to first injection
- ✕Immunocompromised, HIV infection, or immunosuppressive therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men
In Brief
A Phase 3 clinical trial evaluating (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine and Comparator: placebo (unspecified) for Condylomata Acuminata. Completed, enrolled 4,065 participants.
Detailed 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).
Study Details
Timeline
Interventions
0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study
0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study