V501 Efficacy Study in Women Aged 18 to 26 (V501-027)

NCT00378560 ↗

Phase 2 Completed 1021 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupDouble-blindPrevention

Summary

A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women

Timeline

Start: 2006-06-12
Primary completion: 2009-09-16
Completion: 2009-09-16

Outcome

Met primary endpoint

paper Combined incidence of persistent infection or disease with HPV 6, 11, 16 or 18 fell by 87.6% (95% confidence interval [CI], 59.2-97.6; P < 0.001) PMID 23331518 ↗

Publications

Results Yoshikawa H, Ebihara K, Tanaka Y, Noda K. Efficacy of quadrivalent human papillomavirus (types 6, 11, 16 and 18) vaccine (GARDASIL) in Japanese women aged 18-26 years. Cancer Sci. 2013 Apr;104(4):465-72. doi: 10.1111/cas.12106. Epub 2013 Mar 7.
Murata S, Shirakawa M, Sugawara Y, Shuto M, Sawata M, Tanaka Y. Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants. Papillomavirus Res. 2020 Dec;10:100205. doi: 10.1016/j.pvr.2020.100205. Epub 2020 Aug 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gardasil	Vaccine	0.5 ml	Other