CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,006 enrolled
Drug / intervention
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine +1 morebiological
Likely dose
Quadrivalent HPV (Types 6, 11, 16, 18) Recombinant Vaccine injection at Day 1, Month 2, and Month 6AI-extracted
Key inclusion· 3
  • ✓Healthy women aged 20 to 45 years
  • ✓Effective contraception use for at least 2 weeks before study start
  • ✓No fever (temperature) within 24 hours before first injection
Key exclusion· 4
  • ✕Prior history of genital warts
  • ✕More than 4 lifetime sexual partners
  • ✕Prior hysterectomy
  • ✕Active or prior cervical disease

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

Search/NCT00834106
NCT00834106Phase 3Completed
CompareCT.gov

A Randomized, Placebo-Controlled, Double-Blind Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine to Investigate the Safety, and Efficacy in Chinese 20 - to 45-Years-Old Women

Merck Sharp & Dohme LLC·interventional·Posted Feb 3, 2009·Updated Feb 4, 2019

In Brief

A Phase 3 clinical trial evaluating Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine and Comparator: placebo (unspecified) for HPV Infections. Completed, enrolled 3,006 participants.

Detailed Summary

A study to test the safety and effectiveness of Quadrivalent HPV (types 6, 11, 16, 18) L1 VLP vaccine against combined incidence of HPV 6/11/16/18-related persistent infection and vaccine type-specific genital disease among Chinese females between the ages of 20 and 45.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHPV Infections
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 3, 2009
Enrollment StartDec 31, 2008
Primary CompletionMay 11, 2012
Study CompletionSep 30, 2016
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 17.4 years ago

Interventions

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

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine injection at Day 1, Month 2, and Month 6.

Comparator: placebo (unspecified)biological

Aluminum-containing Vaccine placebo injection at Day 1, Month 2, and Month 6.