CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 924 enrolled
Drug / intervention
V503 +1 morebiological
Likely dose
V503 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/NCT01047345
NCT01047345Phase 3Completed
CompareCT.gov

A Phase III, Randomized, International, Placebo-Controlled, Double-Blind Clinical Trial to Study the Tolerability and Immunogenicity of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Given to Females 12-26 Years of Age Who Have Previously Received GARDASIL™

Merck Sharp & Dohme LLC·interventional·Posted Jan 12, 2010·Updated Nov 27, 2018

In Brief

A Phase 3 clinical trial evaluating V503 and Placebo to V503 for Cervical Cancers and 3 related conditions. Completed, enrolled 924 participants.

Detailed Summary

This study will evaluate whether V503 (9vHPV vaccine), is well tolerated in girls and women between 12 and 26 years old who have previously been vaccinated with GARDASIL™. Participants will receive vaccination with 9vHPV vaccine or placebo on Day 1, Month 2, and Month 6 of the Base Study. Participants who receive placebo in the Base Study will be eligible to receive vaccination with 9vHPV vaccine on Day 1, Month 2, and Month 6 of the Extension Study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancers, Vulvar Cancers, Vaginal Cancers, Genital Warts
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 12, 2010
Enrollment StartFeb 24, 2010
Primary CompletionJun 10, 2011
Study CompletionNov 28, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.5 years ago

Interventions

V503biological

V503 (9vHPV) vaccine given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study or the Study Extension

Placebo to V503biological

Placebo to V503 (saline) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study