CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,212 enrolled
Drug / intervention
GSK580299 (CervarixTM) +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/NCT01277042
NCT01277042Phase 3Completed
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Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK 580299) in Healthy Adult Chinese Female Subjects

GlaxoSmithKline·interventional·Posted Jan 14, 2011·Updated Aug 17, 2018

In Brief

A Phase 3 clinical trial evaluating GSK580299 (CervarixTM) and Engerix-BTM for Infections, Papillomavirus. Completed, enrolled 1,212 participants across 1 site.

Detailed Summary

This study is designed to evaluate the immunogenicity and safety of GSK Biologicals' human papillomavirus (HPV) vaccine in adult female subjects aged 26-45 years. One group of subjects will receive the HPV vaccine and the other group will receive an active control (GSK Biologicals' hepatitis B vaccine). Immunogenicity data of the HPV group will be compared with those from the HPV group included in the NCT00779766 study (aged 18-25 years).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Papillomavirus
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 14, 2011
Enrollment StartFeb 17, 2011
Primary CompletionSep 26, 2011
Study CompletionFeb 28, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 15.5 years ago

Interventions

GSK580299 (CervarixTM)biological

3-dose schedule intramuscularly vaccination (Months 0, 1 and 6)

Engerix-BTMbiological

3-dose schedule intramuscularly vaccination (Months 0, 1 and 6)