CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 148 enrolled
Drug / intervention
Cervarix +2 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/NCT01627561
NCT01627561Phase 3Completed
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Safety and Immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) in Healthy Female Children 4-6 Years Old

GlaxoSmithKline·interventional·Posted Jun 26, 2012·Updated Apr 10, 2020

In Brief

A Phase 3 clinical trial evaluating Cervarix, Priorix, and 1 other intervention for Infections, Papillomavirus. Completed, enrolled 148 participants across 4 sites in 3 countries.

Detailed Summary

The current study evaluates the immunogenicity and safety in 4-6 years old female subjects (experimental group) receiving Cervarix according to a 2-dose schedule (Month 0, 6), as compared to 4-6 years old female subjects (control group) receiving sequentially Priorix (Month 0) and Infanrix (Month 6) vaccines.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Papillomavirus
CountriesColombia, Mexico, Panama
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 26, 2012
Enrollment StartOct 15, 2012
Primary CompletionApr 23, 2014
Study CompletionOct 6, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.0 years ago

Interventions

Cervarixbiological

2 doses administered intramuscularly in the deltoid muscle of the left arm at Day 0 and Month 6.

Priorixbiological

1 dose administered intramuscularly in the deltoid muscle of the left arm at Day 0.

Infanrixbiological

1 dose administered intramuscularly in the deltoid muscle of the left arm at Month 6.