At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,504 enrolled
Drug / intervention
Nimenrix +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.
Non-inferiority of GSK Biologicals' Meningococcal Vaccine GSK134612 Versus Mencevax™ in Healthy Subjects Aged 2 Through 10 Years of Age
In Brief
A Phase 3 clinical trial evaluating Nimenrix and Mencevax for Infections, Meningococcal and Meningococcal Vaccines. Completed, enrolled 1,504 participants across 7 sites in 4 countries.
Detailed Summary
The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™. 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, Meningococcal Vaccines
CountriesIndia, Lebanon, Philippines, Saudi Arabia
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2007
Enrollment StartSep 2007
Primary CompletionSep 2008
Study CompletionJan 2009
TodayJul 2026
First PostedAug 10, 2007
Enrollment StartSep 18, 2007
Primary CompletionSep 3, 2008
Study CompletionJan 6, 2009
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 18.9 years ago
Interventions
Nimenrixbiological
Single dose, intramuscular injection
Mencevaxbiological
Single dose, subcutaneous injection