FUTURE IIA 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)
Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine
+ Matching Placebo
Urogenital Diseases+27
+ Genital Diseases
+ Uterine Cervical Diseases
Prevention Study
Summary
Study start date: June 14, 2002
Actual date on which the first participant was enrolled.In the 4-year Base Study (V501-015) (NCT00092534), participants were randomized in a 1:1 order to receive 3 doses of GARDASIL™ 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 GARDASIL™ in the Base Study, were given 3 doses of open-label GARDASIL™ 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 GARDASIL™ in the Base Study were given 1 dose of GARDASIL™ 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 GARDASIL™ was assessed during a period of 10 years following completion of the Base Study (V501-015) \[14 years after the first dose of GARDASIL™\] and, for some measures, the Base Study EXT (V501-015-10) \[10 years after the first dose of GARDASIL™\]. 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 GARDASIL™. 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.12167 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 16 to 23 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives