NCT00834106

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,006 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• HPV Infections

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine	Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine injection at Day 1, Month 2, and Month 6.
BIOLOGICAL	Comparator: placebo (unspecified)	Aluminum-containing Vaccine placebo injection at Day 1, Month 2, and Month 6.

Timeline

• Start date: 2008-12-31
• Primary completion: 2012-05-11
• Completion: 2016-09-30
• First posted: 2009-02-03
• Last updated: 2019-02-04
• Results posted: 2017-10-12

Regulatory

• FDA-regulated drug study