NCT00092521

Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED)

A Study to Evaluate the Efficacy of Quadrivalent HPV Vaccine in Reducing the Incidence of HPV 6-, 11-, 16-, and 18-Related CIN, AIS, and Cervical Cancer, and HPV 6-, 11-, 16-, and 18-Related External Genital Warts, Vulvar Intraepithelial Neoplasia Vaginal Intraepithelial Neoplasia, Vulvar Cancer, and Vaginal Cancer in 16- to 23-Year-Old Women

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,759 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 16 Years – 23 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of the study is to determine if GARDASIL (V501) with four components is able to prevent cervical cancer, cervical dysplasia, including Cervical Intraepithelial Neoplasia (CIN)(Any Grade) and Adenocarcinoma In Situ (AIS), and genital warts.

Conditions

• Cervical Cancer
• Genital Warts

Interventions

Type	Name	Description
BIOLOGICAL	V501	Final Manufactured Product (FMP) quadrivalent HPV vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.
BIOLOGICAL	Comparator: Placebo	a 0.5 mL intramuscular placebo injection given at Day 1, Month 2 and Month 6.
BIOLOGICAL	Human Papillomavirus (HPV) 16 Monovalent	HPV 16 Monovalent vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.

Timeline

• Start date: 2001-12-01
• Primary completion: 2007-07-01
• Completion: 2009-01-01
• First posted: 2004-09-28
• Last updated: 2015-09-25
• Results posted: 2009-11-20