Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)

Condyloma Acuminata Clinical Trial

Official title: A Phase III Placebo-controlled Clinical Trial to Study the Tolerability, Immunogenicity and Efficacy of V501 in 16- to 26-year-old Japanese Men

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Anogenital Human Papilloma Virus Infection
• Condyloma Acuminata
• Papilloma
• Papillomavirus Infections
• Virus Diseases

• NCT number: NCT01862874
• Study type: Interventional
• Source: Merck Sharp & Dohme Corp.
• Status: Completed
• Phase: Phase 3
• Start date: June 27, 2013
• Completion date: August 30, 2017