CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5,752 enrolled
Drug / intervention
Cervarix +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00294047
NCT00294047Phase 3Completed
CompareCT.gov

A Study to Evaluate Safety, Immunogenicity and Efficacy of GSK Biologicals HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a Three-dose Schedule (0, 1, 6 Month) in Healthy Adult Female Subjects Aged 26 Years and Above

GlaxoSmithKline·interventional·Posted Feb 20, 2006·Updated Jan 2, 2020

In Brief

A Phase 3 clinical trial evaluating Cervarix and Placebo control for Infections, Papillomavirus and Papillomavirus Vaccines. Completed, enrolled 5,752 participants across 75 sites in 12 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Papillomavirus, Papillomavirus Vaccines
CountriesAustralia, Canada, Mexico, Netherlands, Peru, Philippines, Portugal, Russia, Singapore, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 20, 2006
Enrollment StartFeb 16, 2006
Primary CompletionJan 29, 2014
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 20.4 years ago

Interventions

Cervarixbiological

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

Placebo controlbiological

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