At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immunogenicity and Safety Study of a Booster Dose of GSK Biologicals' Meningococcal Vaccine 134612 Given at 12-15 Months of Age or at 15-18 Months of Age (Co-administered With Infanrix®) in Primed Healthy Toddlers.
In Brief
A Phase 3 clinical trial evaluating GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix), GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix), and 3 other interventions for Infections, Meningococcal. Completed, enrolled 1,558 participants across 56 sites.
Detailed Summary
The purpose of the study is to characterize the immunogenicity \& safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and open-label for the booster phase.
Study Details
Timeline
Interventions
One dose in the booster phase as intramuscular injection
Three doses in the priming phase and, for Menhibrix 2 Group, one dose in the booster phase as intramuscular injection
One dose as intramuscular injection
Three doses in the priming phase as intramuscular injection
Three doses in the priming phase as intramuscular injection