CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,054 enrolled
Drug / intervention
V503 Vaccine +2 morebiological
Likely dose
V503 Vaccine 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/NCT01073293
NCT01073293Phase 3Completed
CompareCT.gov

A Phase III Open-Label Clinical Trial to Study the Immunogenicity and Tolerability of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Given Concomitantly With REPEVAX™ in Preadolescents and Adolescents (11 to 15 Year Olds)

Merck Sharp & Dohme LLC·interventional·Posted Feb 23, 2010·Updated Nov 27, 2018

In Brief

A Phase 3 clinical trial evaluating V503 Vaccine, REPEVAX™ (Concomitant), and 1 other intervention for Papillomavirus Infections. Completed, enrolled 1,054 participants.

Detailed Summary

This study will evaluate whether co-administration of the first dose of V503 and REPEVAX™ is well tolerated and causes a non-inferior immune response when compared to administration of REPEVAX™ one month following the first dose of V503.

Study Details

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

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 23, 2010
Enrollment StartApr 22, 2010
Primary CompletionJun 16, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 16.4 years ago

Interventions

V503 Vaccinebiological

V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

REPEVAX™ (Concomitant)biological

REPEVAX™ given as a single 0.5 mL intramuscular injection at Day 1

REPEVAX™ (Non-concomitant)biological

REPEVAX™ given as a single 0.5 mL intramuscular injection at Month 1