CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,300 enrolled
Drug / intervention
Meningococcal vaccine GSK134612 +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/NCT01755689
NCT01755689Phase 3Completed
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Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine 134612 With or Without Co-administration of Cervarix and Boostrix in Female Adolescents and Young Adults at 9-25 Years of Age

GlaxoSmithKline·interventional·Posted Dec 24, 2012·Updated Jul 3, 2018

In Brief

A Phase 3 clinical trial evaluating Meningococcal vaccine GSK134612, Cervarix®, and 1 other intervention for Infections, Meningococcal. Completed, enrolled 1,300 participants across 3 sites in 3 countries.

Detailed Summary

The purpose of this study is to evaluate safety and immunogenicity of GSK Biologicals' meningococcal vaccine GSK134612 (MenACWY-TT) co-administered with Cervarix as compared to MenACWY-TT and Cervarix administered alone and the co-administration of MenACWY-TT with Cervarix and Boostrix as compared to MenACWY-TT administered alone and Cervarix co-administered with Boostrix.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Meningococcal
CountriesDominican Republic, Estonia, Thailand
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 24, 2012
Enrollment StartJan 11, 2013
Primary CompletionApr 29, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.5 years ago

Interventions

Meningococcal vaccine GSK134612biological

One dose administered intramuscularly (IM) in the deltoid of the right arm.

Cervarix®biological

Three doses administered intramuscularly (IM) in the deltoid of the left arm.

Boostrix®biological

One dose administered intramuscularly (IM) in the deltoid of the left arm.