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

NCT00092521 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5759

Last updated 2015-09-25

Study results available
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Summary

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.

Conditions

Interventions

BIOLOGICAL

V501

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

BIOLOGICAL

Comparator: Placebo

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

BIOLOGICAL

Human Papillomavirus (HPV) 16 Monovalent

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

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
23 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-12-31
Primary Completion
2007-07-31
Completion
2009-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00092521 on ClinicalTrials.gov