Study to Test the Safety of HPV Vaccine in Women (V501-011)(COMPLETED)

Phase 3CompletedNCT00517309

Merck Sharp & Dohme LLC1,877 enrolled

Overview

The primary purpose of the study is to test the safety of HPV Vaccine in Women

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,877

Conditions

Cervical Cancer Genital Warts

Interventions

V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 YearsBIOLOGICAL

Comparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 YearsBIOLOGICAL

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Females age 16 to 23 years old * Must agree to refrain from sexual activity (vaginal or anal) for 48 hours prior to any scheduled visit Exclusion Criteria: * History of vaccination with an HPV vaccine * History of hepatitis B infection * History of vaccination with hepatitis B vaccine * History of genital warts or treatment for genital warts

Outcomes

Primary Outcomes

Quadrivalent HPV vaccine is generally well tolerated when administered alone or concomitantly with hepatitis B vaccine.

Secondary Outcomes

HPV vaccine is well tolerated in 16-23 year old females.

Data from ClinicalTrials.gov

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