CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 199 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/NCT01249365
NCT01249365Phase 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 Nov 29, 2010·Updated Nov 13, 2019

In Brief

A Phase 3 clinical trial evaluating GSK580299 (Cervarix) for Infections, Papillomavirus. Completed, enrolled 199 participants across 15 sites in 4 countries.

Detailed Summary

This extension study is designed to assess the safety of GSK Biological's 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
CountriesAustralia, Portugal, Russia, Singapore
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 29, 2010
Enrollment StartJan 24, 2011
Primary CompletionJan 10, 2017
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 15.6 years ago

Interventions

GSK580299 (Cervarix)biological

3-dose schedule intramuscularly vaccination