CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 14,840 enrolled
Drug / intervention
Comparator: GARDASIL +1 morebiological
Likely dose
Comparator: GARDASIL 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00543543
NCT00543543Phase 3Completed
CompareCT.gov

A Randomized, International, Double-Blinded (With In-House Blinding), Controlled With GARDASIL, Dose-Ranging, Tolerability, Immunogenicity, and Efficacy Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 16- to 26- Year-Old Women

Merck Sharp & Dohme LLC·interventional·Posted Oct 15, 2007·Updated Nov 27, 2018

In Brief

A Phase 3 clinical trial evaluating Comparator: GARDASIL and Experimental: V503 for Cervical Cancer and 4 related conditions. Completed, enrolled 14,840 participants.

Detailed Summary

The purpose of this study was to evaluate the safety, efficacy, and immunogenicity of V503 in comparison to GARDASIL. The primary hypotheses tested in the study were 1) V503 administered to 16- to 26-year-old adolescents and young women is generally well-tolerated, 2) V503 reduces combined incidence of Human Papillomavirus (HPV) Type 31/33/45/52/58-related disease compared with GARDASIL, and 3) V503 induces non-inferior geometric mean titers for HPV Type 6/11/16/18 antibodies compared with GARDASIL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts, Human Papillomavirus Infection
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 15, 2007
Enrollment StartSep 24, 2007
Primary CompletionApr 10, 2013
Study CompletionJul 7, 2016
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 18.7 years ago

Interventions

Comparator: GARDASILbiological

GARDASIL (quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine), 0.5 mL injection in 3 dose regimen

Experimental: V503biological

V503 (9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine), 0.5 mL injection in 3 dose regimen (and a fourth injection for Cohort 1 only).