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

Merck Sharp & Dohme LLC3,882 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

3,882

Conditions

Cervical Cancer Genital Warts

Interventions

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

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 23 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Tolerability and immune responses at week 4 post dose 3.

Data from ClinicalTrials.gov

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