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

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.

Timeline

Start

2013-06-27

Primary completion

2017-08-30

Completion

2017-08-30

Publications

• Results Mikamo H, Yamagishi Y, Murata S, Yokokawa R, Han SR, Wakana A, Sawata M, Tanaka Y. Efficacy, safety, and immunogenicity of a quadrivalent HPV vaccine in Japanese men: A randomized, Phase 3, placebo-controlled study. Vaccine. 2019 Mar 14;37(12):1651-1658. doi: 10.1016/j.vaccine.2019.01.069. Epub 2019 Feb 20.

Drugs

Indications