A Randomized, Worldwide, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Immunogenicity, and Efficacy on the Incidence of HPV 16/18-Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year Old Women - The FUTURE II Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)
A Randomized, Worldwide, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Immunogenicity, and Efficacy on the Incidence of HPV 16/18-Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year Old Women - The FUTURE II Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)
The primary purpose of the study is to determine if GARDASILâ„¢ (V501) is able to prevent cervical cancer.
In the 4-year Base Study (V501-015) (NCT00092534), participants were randomized in a 1:1 order to receive 3 doses of GARDASILâ„¢ or matching placebo at Day 1, Month 2, and Month 6 and were assessed for efficacy, immunogenicity, and safety.
In the Base Study Extension (EXT) [V501-015-10], participants who received placebo or only 1 dose of GARDASILâ„¢ in the Base Study, were given 3 doses of open-label GARDASILâ„¢ at EXT Day 1, EXT Month 2, and EXT Month 6, and were followed to EXT Month 7. Participants who who received 2 doses of GARDASILâ„¢ in the Base Study were given 1 dose of GARDASILâ„¢ at EXT Day 1 and were followed for 15 days (day of vaccination plus 14 days).
In the 10-year Base Study Long-Term Follow-Up (LTFU) [V501-015-21] the effectiveness, immunogenicity and safety of GARDASILâ„¢ was assessed during a period of 10 years following completion of the Base Study (V501-015) [14 years after the first dose of GARDASILâ„¢] and, for some measures, the Base Study EXT (V501-015-10) [10 years after the first dose of GARDASILâ„¢]. Participants from Denmark, Iceland, Norway and Sweden who participated in the Base Study were eligible to enroll in the LTFU. Effectiveness and safety was assessed by registry-based follow-up, and immunogenicity was assessed by serological testing at approximately Year 5 and Year 10 of the V501-015-21 LTFU.
An 8-year extension was added to the LTFU (V501-015-22] to continue the evaluation of the long-term effectiveness and immunogenicity of GARDASILâ„¢. Effectiveness and safety will be assessed by registry-based follow-up, and immunogenicity will be assessed by serological testing at approximately Year 4 and Year 8 of the extension of the LTFU.
Inclusion Criteria for the Base Study:
Healthy women with an intact uterus with lifetime history of 0-4 sexual partners
--For Extension Phase:
Participant received placebo or an incomplete vaccination series in the original study
--For LTFU:
Participant was randomized into the Base Study from Denmark, Iceland, Norway, or Sweden.
Agreed to allow passive follow-up (retrospective review of registry data), analysis of biopsy specimens, future contact from National Registry Study Center and serum collection
Exclusion Criteria for the Base Study:
Prior Human Papilloma Virus (HPV) vaccination
Prior abnormal Paps
Prior history of genital warts
--For Extension Phase:
Prior complete HPV vaccination series
Subject lives in a country in which Gardasil is approved and is within the age range of the local labeling for Gardasil
--For LTFU Study:
There were no exclusion criteria that did not overlap the inclusion criteria for this study.