Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)

Phase 2CompletedNCT00520598

Merck Sharp & Dohme LLC511 enrolled

Overview

The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

511

Conditions

Cervical Cancer Vulvar Cancer Vaginal Cancer Genital Warts Human Papillomavirus Infection

Interventions

Comparator: V505 formulation 1BIOLOGICAL

0.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6.

Comparator: V505 formulation 2DRUG

0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6.

Comparator: V505 formulation 2DRUG

0.5 ml injection of V505 formulation 2 as 2 dose regimen at Day 1 and Month 6.

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Female between 16 to 26 years old * Has never had Pap testing or have 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 any 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 time of consent)

Outcomes

Primary Outcomes

Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen

Time frame: 4 weeks post dose 3

Secondary Outcomes

Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 2-dose regimen

Time frame: 4 weeks post dose 2

Data from ClinicalTrials.gov

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