At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 414 enrolled
Drug / intervention
GSK Biologicals' meningococcal vaccine GSK134612 +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) Compared to Licensed MenC-CRM197 Conjugate Vaccine in Healthy Children
In Brief
A Phase 3 clinical trial evaluating GSK Biologicals' meningococcal vaccine GSK134612 and Menjugate for Infections, Meningococcal. Completed, enrolled 414 participants across 31 sites in 2 countries.
Detailed Summary
The purpose of the study is to investigate whether or not GSK Biologicals' meningococcal vaccine GSK134612 is inferior to a licensed MenC-CRM197 conjugate vaccine in terms of vaccine antibody response against meningococcal serogroup C disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Meningococcal
CountriesFrance, Germany
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2008
Enrollment StartMay 2008
Primary CompletionSep 2008
Study CompletionJan 2009
TodayJul 2026
First PostedMay 8, 2008
Enrollment StartMay 9, 2008
Primary CompletionSep 2, 2008
Study CompletionJan 8, 2009
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 18.2 years ago
Interventions
GSK Biologicals' meningococcal vaccine GSK134612biological
Intramuscular administration, 1 dose
Menjugatebiological
Intramuscular administration, 1 dose