CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,520 enrolled
Drug / intervention
9vHPV Vaccinebiological
Likely dose
9vHPV 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/NCT01651949
NCT01651949Phase 3Completed
CompareCT.gov

A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of 9vHPV (V503), a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, in 16- to 26-Year-Old Men and 16- to 26-Year-Old Women

Merck Sharp & Dohme LLC·interventional·Posted Jul 27, 2012·Updated Nov 27, 2018

In Brief

A Phase 3 clinical trial evaluating 9vHPV Vaccine for Genital Warts and 2 related conditions. Completed, enrolled 2,520 participants.

Detailed Summary

This study is designed to evaluate the immunogenicity and tolerability of 9vHPV (9-valent HPV vaccine, V503) in 16- to 26-year old men and women. The overall goal is to bridge 9vHPV efficacy findings in young women to young men based on the demonstration of similar immunogenicity and safety profiles. The primary hypothesis is that 9vHPV induces antibody responses at 4 weeks postdose 3 in heterosexual males that are non-inferior to antibody responses in young women.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGenital Warts, Anal Cancer, Anal Intraepithelial Neoplasia
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 27, 2012
Enrollment StartOct 29, 2012
Primary CompletionAug 4, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.9 years ago

Interventions

9vHPV Vaccinebiological

9vHPV, 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