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Study of Human Papillomavirus (HPV) 16 Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females (V501-005)

NCT00365378 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2409

Last updated 2015-10-23

Study results available
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Summary

Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy, immunogenicity, and safety.

Conditions

  • HPV 16 Infection

Interventions

BIOLOGICAL

Comparator: HPV 16 L1 Vaccine

A 0.5 intramuscular injection given at Day 1, Month 2, and Month 6

BIOLOGICAL

Comparator: Placebo

A 0.5 intramuscular placebo 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
1999-09-30
Primary Completion
2004-03-31
Completion
2009-07-31

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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 NCT00365378 on ClinicalTrials.gov