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

Phase 3

Completed

• Conditions: Cervical Cancer; Genital Warts
• Interventions: Biological: Human Papillomavirus (HPV) 16 Monovalent; Biological: V501

• Registration Number: NCT00092521
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-12
• Study First Submitted: 2004-09-23
• Study First Submitted QC: 2004-09-27
• Study First Posted: 2004-09-28
• Primary Completion: 2007-07
• Study Completion: 2009-01
• Results First Submitted: 2009-08-03
• Results First Submitted QC: 2009-10-19
• Results First Posted: 2009-11-20
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-24
• Last Update Posted: 2015-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5759

Inclusion Criteria

• Female with an intact uterus with lifetime history of 0-4 sexual partners

Exclusion Criteria

• Prior Human Papillomavirus (HPV) vaccination
• Prior abnormal paps
• History of genital warts

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Human Papillomavirus (HPV) 16 Monovalent	HPV 16 Monovalent Vaccine
1	V501	V501

Primary Outcome Measures

Name	Time	Method
Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer	Follow-up through end of study (4 years)
Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer]	Follow-up through end of study (4 years)