CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 137 enrolled
Drug / intervention
GSK580299 (Cervarix)biological
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/NCT01190189
NCT01190189Phase 3Completed
CompareCT.gov

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Control Subjects From the Primary NCT00294047 Study

GlaxoSmithKline·interventional·Posted Aug 27, 2010·Updated Jun 19, 2019

In Brief

A Phase 3 clinical trial evaluating GSK580299 (Cervarix) for Infections, Papillomavirus. Completed, enrolled 137 participants across 28 sites in 2 countries.

Detailed Summary

This extension study is designed to assess the safety of GSK Biological's human papillomavirus (HPV) vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the subject's age group (26 years and older). This study is thus conducted to enable all women who received the control placebo in the primary NCT00294047 study to receive the GSK580299 vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Papillomavirus
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 27, 2010
Enrollment StartApr 1, 2011
Primary CompletionNov 23, 2017
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 15.8 years ago

Interventions

GSK580299 (Cervarix)biological

3-dose schedule intramuscularly vaccination