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A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501, qHPV) in Mid-Adult Women (V501-019)

NCT00090220 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3819

Last updated 2017-04-21

Study results available
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Summary

This study was conducted to assess the safety, immunogenicity, efficacy and long-term effectiveness of a vaccine being evaluated for the prevention of human papillomavirus (HPV) infection and disease in mid-adult women.

Conditions

  • Healthy Adult Female Participants
  • Prevention
  • Papillomavirus Infection
  • Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Interventions

BIOLOGICAL

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

qHPV intramuscular injection in three 0.5 mL doses over 6 months in the Base Study or EXT1

BIOLOGICAL

Comparator: Placebo

Placebo intramuscular injection in three 0.5 mL doses over 6 months.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
24 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-06-16
Primary Completion
2009-05-21
Completion
2015-11-12

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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 NCT00090220 on ClinicalTrials.gov