CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,055 enrolled
Drug / intervention
V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccinebiological
Likely dose
Quadrivalent HPV vaccine (types 6, 11, 16, 18) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6AI-extracted
Key inclusion· 2
  • ✓Healthy adolescents and pre-adolescents with no prior sexual history
  • ✓Healthy women with intact uterus and lifetime history of 0-4 sexual partners
Key exclusion· 3
  • ✕Prior HPV vaccination
  • ✕Prior abnormal Pap smears
  • ✕Prior history of genital warts

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

Search/NCT00092495
NCT00092495Phase 3Completed
CompareCT.gov

A Study to Demonstrate Immunogenicity and Tolerability of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents, and To Determine End-Expiry Specifications for the Vaccine

Merck Sharp & Dohme LLC·interventional·Posted Sep 27, 2004·Updated Jan 13, 2015

In Brief

A Phase 3 clinical trial evaluating V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine for Cervical Cancer and Genital Warts. Completed, enrolled 3,055 participants.

Detailed Summary

The primary purpose of the study is to determine if an investigational vaccine Gardasil (V501) with 4 components will provide an immune response and will be well tolerated in pre-adolescents and adolescents.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer, Genital Warts
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 27, 2004
Enrollment StartDec 1, 2002
Primary CompletionSep 1, 2004
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 21.8 years ago

Interventions

V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccinebiological

qHPV Vaccine (20, 40, 60 or 100% dose formulation) 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.