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Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil) (V501-015)

NCT00092534 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12167

Last updated 2025-08-01

Study results available
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Summary

The primary purpose of the study is to determine if GARDASIL™ (V501) is able to prevent cervical cancer.

Conditions

Interventions

BIOLOGICAL

Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine

A 0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study.

BIOLOGICAL

Matching Placebo

A placebo 0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2002-06-14
Primary Completion
2007-07-31
Completion
2025-06-13

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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 NCT00092534 on ClinicalTrials.gov