A Randomized, Worldwide, Placebo-Controlled, Double-Blind Study to Investigate the Safety Immunogenicity and Efficacy on the Incidence of HPV 16/18-Related CIN2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18,) L1 Virus-Like Particle (VLP) Vaccine (V501, Gardasil) in 16- to 23-Year Old Women - The F.U.T.U.R.E. II Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)
The original base study (V501-015) (NCT00092534) was extended in protocol V501-015-10.
Subjects in the placebo arm of the base study were given 3 doses of open-label GARDASIL™
(V501) at Extension (EXT) Day 1, EXT Month 2 and EXT Month 6 and were followed to EXT Month
7. Subjects who received only 1 dose of GARDASIL™ in the base study were given 3 doses of
open-label GARDASIL™ (V501) at Extension (EXT) Day 1, EXT Month 2 and EXT Month 6 and were
followed to EXT Month 7. Subjects who received 2 doses of GARDASIL™ in the base study were
given only 1 dose of GARDASIL™ at EXT Day 1 and were followed for 15 days (day of
vaccination plus 14 days).
A second extension study, V501-015-20, will assess the effectiveness, immunogenicity and
safety of GARDASIL™ during a period of 10-14 years following completion of the base study
(V501-015) or the V501-015-10 extension. Subjects from Denmark, Iceland, Norway and Sweden
who participated in the base study were eligible to enroll. Effectiveness and safety will be
assessed by registry-based follow-up. Immunogenicity will be assessed by serological testing
at approximately Year 5 and Year 10 of the V501-015-20 extension, respectively.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Tolerability; Incidence of the Composite Endpoint of HPV 16 or HPV 18 Related CIN2/3 or Invasive Cervical Carcinoma After Completion of the Vaccination Series for Relevant HPV Type
Tolerability = Number of subjected affected. Incidence Rate per person-years of follow-up. The tolerability objective was to demonstrate that Gardasil is generally well tolerated by females aged 16-23. The relevant data are presented in the Reported Adverse Events section. No formal statistical hypothesis testing were performed for this objective.
Follow-up through end of study (4 years)
United States: Food and Drug Administration