NCT01862874

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,124 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Male
• Age: 16 Years – 26 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anogenital Human Papilloma Virus Infection
• Condyloma Acuminata

Interventions

Type	Name	Description
BIOLOGICAL	V501	Formulated with aluminum hydroxyphosphate sulfate (AAHS) adjuvant
BIOLOGICAL	Placebo	Formulated with AAHS adjuvant

Timeline

• Start date: 2013-06-27
• Primary completion: 2017-08-30
• Completion: 2017-08-30
• First posted: 2013-05-27
• Last updated: 2019-04-02
• Results posted: 2018-08-31