Broad Spectrum HPV Vaccine Tolerability, Immunogenicity, and Efficacy Study (V502-003)

Merck Sharp & Dohme LLC

Overview

This study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate prevention of cervical, vulvar, and vaginal cancers and related precancers, external genital lesions, and persistent infection caused by the HPV types in the study vaccine, (2) To demonstrate that the vaccine is well-tolerated in women, (3) To evaluate vaccine immune responses in women. This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Conditions

Cervical Cancer Condylomata Acuminata

Interventions

V502BIOLOGICAL

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Female, between the ages of 16 and 26 Exclusion Criteria: * History of an abnormal PAP test or abnormal cervical biopsy result * History of external genital/vaginal warts * History of positive HPV test * Currently a user of any illegal drugs or an alcohol abuser * Are pregnant * Currently enrolled in another 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

Proprietary Information - Exploratory (Non-Confirmatory) Trial

Secondary Outcomes

Proprietary Information - Exploratory (Non-Confirmatory) Trial

Data from ClinicalTrials.gov

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