An Investigational Study of Gardasil™ (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)
Condition: Condylomata Acuminata
MeSH terms: Condylomata Acuminata
Intervention: (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine; Comparator: placebo (unspecified)
Intervention description: 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
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4065.0
Sex: Male
Minimum age: 16 Years
Maximum age: 26 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: anogenital warts

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).
    

Eligibility criteria:

        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