CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 793 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/NCT00508261
NCT00508261Phase 3Completed
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Co-Administration of GSK Biologicals' Meningococcal Vaccine GSK134612 With Infanrix Hexa™, Compared to Individual Administration of Each Vaccine, in Healthy 12- Through 23-Month-Old Children

GlaxoSmithKline·interventional·Posted Jul 27, 2007·Updated Jan 24, 2019

In Brief

A Phase 3 clinical trial evaluating Meningococcal vaccine GSK134612, Infanrix™ hexa, and 1 other intervention for Infections, Meningococcal. Completed, enrolled 793 participants across 89 sites in 3 countries.

Detailed Summary

The purpose of this study is to demonstrate, in 12-23 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 co-administered with Infanrix hexa™, compared to each vaccine administered individually and to licensed meningococcal vaccine Meningitec™. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Meningococcal
CountriesAustria, Germany, Greece
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 27, 2007
Enrollment StartAug 1, 2007
Primary CompletionMay 26, 2008
Study CompletionOct 27, 2008
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 18.9 years ago

Interventions

Meningococcal vaccine GSK134612biological

Single dose intramuscular injection

Infanrix™ hexabiological

Single dose intramuscular injection

Meningitec™biological

Single dose intramuscular injection