Safety, Immunogenicity, and Efficacy of Gardasil (V501 (Human Papilloma Virus [Types 6, 11, 16, 18] Recombinant Vaccine) in Mid-Adult Women - The FUTURE III (Females United to Unilaterally Reduce Endo/Ectocervical Cancer) Study
The base study (V501-019) 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 48.
The base study was extended in protocol V501-019-10 (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 Long Term Follow-Up (LTFU) extension study V501-019-20 (EXT2) will observe the long term
safety, effectiveness, and immunogenicity of GARDASIL™ in 1,600 women who participated in
the base protocol in Colombia. Data will be collected over a period of 6-10 years following
subjects' enrollment in the original base protocol.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Combined Incidence of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, Vulvar Intraepithelial Neoplasia (VIN), Vaginal Intraepithelial Neoplasia (VaIN), Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, AIS, and Cervical Cancer
HPV 6/11/16/18: The four types of HPV (types 6/11/16/18) were determined by polymerase chain reaction (PCR) testing
Base Study: through Month 48
United States: Food and Drug Administration