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Study to Evaluate the Efficacy of the Human Papillomavirus Vaccine in Healthy Adult Women of 26 Years of Age and Older

NCT00294047 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5752

Last updated 2020-01-02

Study results available
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Summary

This is a multicentre study in which women were planned to receive either the Human Papillomavirus Vaccine (HPV) vaccine or control. Under Protocol Amendment 3, study participation will last approximately 48 months and involves a total of eleven scheduled visits. Under Protocol Amendment 4, study participation will last up to 84 months and involves a maximum of seventeen scheduled visits.

Conditions

  • Infections, Papillomavirus
  • Papillomavirus Vaccines

Interventions

BIOLOGICAL

Cervarix

Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

BIOLOGICAL

Placebo control

Subjects were planned to receive three doses of the control vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
26 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-02-16
Primary Completion
2014-01-29
Completion
2014-01-29

Countries

  • United States
  • Australia
  • Canada
  • Mexico
  • Netherlands
  • Peru
  • Philippines
  • Portugal
  • Russia
  • Singapore
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT00294047 on ClinicalTrials.gov