A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED)

Merck Sharp & Dohme LLC620 enrolled

Overview

The purpose of this study is to evaluate vaccine immunogenicity and how well the body tolerates V504 when given with Gardasil.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

620

Conditions

Cervical Cancer Vulvar Cancer Vaginal Cancer Genital Warts Human Papillomavirus Infection

Interventions

V504BIOLOGICAL

V504 0.5 ml injection in 3 dose regimen for 6 month treatment period.

Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant VaccineBIOLOGICAL

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 0.5 ml injection in 3 dose regimen for 6 month treatment period.

Comparator: Placebo (unspecified)BIOLOGICAL

V504 Placebo in 3 dose regimen for 6 month treatment period.

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 26 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Females between 16- to 26-years-old * Has never had Pap testing or has only had normal Pap test results. * Lifetime history of 0 to 4 sexual partners Exclusion Criteria: * History of an abnormal cervical biopsy result * History of a positive test for HPV; History of external genital/vaginal warts * Currently a user of illegal drugs or an alcohol abuser * History of severe allergic reaction that required medical attention * Are pregnant * Received a marketed HPV vaccine * Currently enrolled in a clinical trial * Currently has or has a history of certain medical conditions or is currently taking or has taken certain medications (details will be discussed at the time of consent)

Outcomes

Primary Outcomes

Geometric mean titers (GMTs) to HPV types contained in the administered vaccines

Time frame: 4 weeks post dose 3

Secondary Outcomes

Seroconversion percentages to HPV types contained in the administered vaccines

Time frame: 4 weeks post dose 3

Data from ClinicalTrials.gov

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