Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED)

Merck Sharp & Dohme LLC5,759 enrolled

Overview

The primary purpose of the study is to determine if GARDASIL (V501) with four components is able to prevent cervical cancer, cervical dysplasia, including Cervical Intraepithelial Neoplasia (CIN)(Any Grade) and Adenocarcinoma In Situ (AIS), and genital warts.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

5,759

Conditions

Cervical Cancer Genital Warts

Interventions

V501BIOLOGICAL

Final Manufactured Product (FMP) quadrivalent HPV vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.

Comparator: PlaceboBIOLOGICAL

a 0.5 mL intramuscular placebo injection given at Day 1, Month 2 and Month 6.

Human Papillomavirus (HPV) 16 MonovalentBIOLOGICAL

HPV 16 Monovalent vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.

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 (HPV) vaccination * Prior abnormal paps * History of genital warts

Outcomes

Primary Outcomes

Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer

Time frame: Follow-up through end of study (4 years)

Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer]

Time frame: Follow-up through end of study (4 years)

Data from ClinicalTrials.gov

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