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 WartsCervical 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
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.
- Secondary Outcome Measures
Name Time Method