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).

Trial Profile

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).

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Jun 2017

At a glance

  • Drugs Human papillomavirus vaccine recombinant quadrivalent Merck (Primary)
  • Indications Adenocarcinoma; Cervical cancer; Cervical intraepithelial neoplasia; Genital warts; Human papillomavirus infections
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms FUTURE-II; LTFU
  • Sponsors Merck Sharp & Dohme
  • Most Recent Events

    • 21 Apr 2017 Status changed from active, no longer recruiting to completed.
    • 06 Dec 2012 Interim results from the Long-Term Follow Up extension study were presented at the 28th International Papillomavirus Conference (IPV).
    • 18 Oct 2012 Planned end date changed from 1 Jan 2018 to 1 Jan 2019 as reported by ClinicalTrials.gov record.
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