FUTURE II
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)
Phase 3N = 12,167NCT00092534
- Population
- Women aged 15 to 26 years
- Design
- Randomised, double-blind, placebo-controlled phase 3 trial of a three-dose quadrivalent HPV-6/11/16/18 vaccine given at day 1, month 2 and month 6.
- Primary endpoint
- HPV 16/18-related CIN 2/3 or worse
- Arms
- Placebo (control): Placebo at day 1, month 2 and month 6
- Quadrivalent HPV vaccine (experimental): HPV-6/11/16/18 vaccine at day 1, month 2 and month 6
- People
- FUTURE II Study Group