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A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)

NCT00092547 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1781

Last updated 2018-02-20

Study results available
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Summary

This study is to evaluate the safety, tolerability, and immune response of an investigational vaccine in preadolescent and adolescent boys and girls for the prevention of Human Papilloma Virus (HPV).

Conditions

  • Human
  • Papillomavirus Infections

Interventions

BIOLOGICAL

V501

0.5 mL intramuscular injection of V501

BIOLOGICAL

Comparator: Placebo

0.5 mL intramuscular injection of placebo

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-10-08
Primary Completion
2005-11-03
Completion
2015-06-01

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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 NCT00092547 on ClinicalTrials.gov