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

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).

Inclusion Criteria:

• Healthy heterosexual males between the ages of 16 years and 23 years and 364 days. Healthy men having sex with men (MSM) between the ages of 16 years and 26 years and 364 days.
• No clinical evidence of genital lesions suggesting sexually-transmitted disease, and no history of anogenital warts
• Additional criteria will be discussed with you by the physician

Exclusion Criteria:

• Concurrently enrolled in a clinical study involving collection of genital specimens
• History of known prior vaccination with an HPV vaccine
• Received an inactivated vaccine within 14 days or a live virus vaccine within 21 days prior to enrollment
• History of a severe allergic reaction that required medical intervention
• Received any immune globulin or blood-derived products within 6 months prior to the first study injection
• History of splenectomy, immune disorders, or receiving immunosuppressives
• Immunocompromised or diagnosed with HIV infection
• Known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
• History of recent or ongoing alcohol or drug abuse