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Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041)

HPV Infections Clinical Trial

Official title:
A Randomized, Placebo-Controlled, Double-Blind Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine to Investigate the Safety, and Efficacy in Chinese 20 - to 45-Years-Old Women

Clinical Trial Summary

A study to test the safety and effectiveness of Quadrivalent HPV (types 6, 11, 16, 18) L1 VLP vaccine against combined incidence of HPV 6/11/16/18-related persistent infection and vaccine type-specific genital disease among Chinese females between the ages of 20 and 45.

Clinical Trial Description

The Base Study V501-041 duration was 30 months. The study was extended to further evaluate the efficacy of Quadrivalent HPV (Type 6, 11, 16, 18) L1 VLP (qHPV) vaccine against Cervical Intraepithelial Neoplasia Grade 2 (CIN 2), CIN 3, Adenocarcinoma In Situ (AIS), and/or cervical cancer. The efficacy was followed through the Month 78 visit, and the close-out visit was conducted at approximately Month 90 with only safety data collected ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00834106
Study type Interventional
Source Merck Sharp & Dohme Corp.
Contact
Status Completed
Phase Phase 3
Start date December 31, 2008
Completion date September 30, 2016
View Details
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