CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,124 enrolled
Drug / intervention
V501 +1 morebiological
Likely dose
Not stated in 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/NCT01862874
NCT01862874Phase 3Completed
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A Phase III Placebo-controlled Clinical Trial to Study the Tolerability, Immunogenicity and Efficacy of V501 in 16- to 26-year-old Japanese Men

Merck Sharp & Dohme LLC·interventional·Posted May 27, 2013·Updated Apr 2, 2019

In Brief

A Phase 3 clinical trial evaluating V501 and Placebo for Anogenital Human Papilloma Virus Infection and Condyloma Acuminata. Completed, enrolled 1,124 participants.

Detailed Summary

A study to evaluate the efficacy and tolerability of V501 (quadrivalent Human Papilloma Virus \[HPV\] \[Type 6, 11, 16 and 18\] L1 Virus-Like Particle vaccine, GARDASIL™) in healthy, 16- to 26-year old Japanese males. The hypotheses tested are: 1) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection compared with placebo, and 2) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, condyloma acuminata, penile/perianal/perineal intraepithelial neoplasia, or penile, perianal, or perineal cancer compared with placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnogenital Human Papilloma Virus Infection, Condyloma Acuminata
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 27, 2013
Enrollment StartJun 27, 2013
Primary CompletionAug 30, 2017
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 13.1 years ago

Interventions

V501biological

Formulated with aluminum hydroxyphosphate sulfate (AAHS) adjuvant

Placebobiological

Formulated with AAHS adjuvant