An Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men
The base study (V501-020) encompassed Day 1 through Month 7, during which time participants
received randomly assigned Gardasil™ (qHPV vaccine) or placebo at Day 1, Month 2, and Month
6. Base study follow-up continued through Month 36.
The base study was extended in protocol V501-020-10 Extension 1 (EXT1). Participants who
received placebo and participants who received only 1 dose of qHPV vaccine in the base study
were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and
Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were
offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants
were followed to EXT1 Month 7.
A second extension study, V501-020-21 (EXT2), will estimate the long-term safety and
effectiveness of qHPV vaccine during a period of 10 years following initial enrollment in
the base study. Subjects who received at least one dose of qHPV vaccine in either the base
study or EXT1 are eligible to enroll in EXT2.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Incidence of Human Papillomavirus (HPV) Related External Genital Warts, Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer
Subjects with HPV 6/11/16/18-related external genital warts, PIN, penile, perianal or perineal cancer per 100 person-years of follow-up.
Base study: through Month 36
United States: Food and Drug Administration