Immunogenicity Bridge Between an Investigational Monovalent Vaccine and the Equivalent Component of Gardasil (V501) a Quadrivalent Vaccine (V501-012)(COMPLETED)

Phase 3

Completed

• Conditions: Genital Warts; Cervical Cancer

• Registration Number: NCT00092482
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of the study is to determine if an investigational vaccine with a single component develops an immune response that is similar to the equivalent investigational vaccine with four components to reduce cervical disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06-28
• Primary Completion: 2004-06-30
• Study First Submitted: 2004-09-22
• Study First Submitted QC: 2004-09-24
• Study First Posted: 2004-09-27
• Study Completion: 2008-08-15
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3882

Inclusion Criteria

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

Exclusion Criteria

• Prior Human Papillomavirus Vaccine (HPV) vaccination;
• Prior abnormal paps;
• Prior history of genital warts

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tolerability and immune responses at week 4 post dose 3.