CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,819 enrolled
Drug / intervention
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine +1 morebiological
Likely dose
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine — qHPV intramuscular injection in three 0.5 mL doses over 6 monthsAI-extracted
Key inclusion· 2
  • ✓No history of genital warts, vulvar intraepithelial neoplasia (VIN), or vaginal intraepithelial neoplasia (VaIN)
  • ✓Not pregnant and agrees to use effective contraception through Month 7 of the study
Key exclusion· 10
  • ✕Pregnant
  • ✕Previously received any HPV vaccine
  • ✕History of severe allergic reaction that required medical intervention
  • ✕Immunocompromised or diagnosed with human immunodeficiency virus (HIV) infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00090220
NCT00090220Phase 3Completed
CompareCT.gov

Safety, Immunogenicity, and Efficacy of Gardasil (V501 (Human Papilloma Virus [Types 6, 11, 16, 18] Recombinant Vaccine) in Mid-Adult Women - The FUTURE III (Females United to Unilaterally Reduce Endo/Ectocervical Cancer) Study

Merck Sharp & Dohme LLC·interventional·Posted Aug 27, 2004·Updated Apr 21, 2017

In Brief

A Phase 3 clinical trial evaluating Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine and Comparator: Placebo for Healthy Adult Female Participants and 3 related conditions. Completed, enrolled 3,819 participants.

Detailed Summary

This study was conducted to assess the safety, immunogenicity, efficacy and long-term effectiveness of a vaccine being evaluated for the prevention of human papillomavirus (HPV) infection and disease in mid-adult women.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Adult Female Participants, Prevention, Papillomavirus Infection, Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 27, 2004
Enrollment StartJun 16, 2004
Primary CompletionMay 21, 2009
Study CompletionNov 12, 2015
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 21.8 years ago

Interventions

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccinebiological

qHPV intramuscular injection in three 0.5 mL doses over 6 months in the Base Study or EXT1

Comparator: Placebobiological

Placebo intramuscular injection in three 0.5 mL doses over 6 months.