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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Genital Warts; Cervical Cancer

Treatments: Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092482

V501-012

2004_080

Details and patient eligibility

About

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.

Enrollment: 3,882 patients

Sex: Female

Ages: 16 to 23 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind