At a glance
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Evaluate Non-Inferiority and Persistence of the Immune Response of GSK Biologicals' Meningococcal Vaccine 134612 Versus Meningitec™ or Mencevax™ ACWY in Healthy Subjects (1-10 Years of Age)
In Brief
A Phase 2 clinical trial evaluating GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix), Mencevax™ ACWY, and 1 other intervention for Infections, Meningococcal. Completed, enrolled 613 participants across 11 sites.
Detailed Summary
This study has 2 phases, a vaccination phase and a long-term follow-up phase. In the vaccination phase of this study, the new meningococcal vaccine 134612 will be evaluated in children using Mencevax™ ACWY (in children above 2 years) or Meningitec™ (in children below 2 years) as controls. In the long-term follow-up phase of the study, the long-term protection offered by the vaccines will be assessed up to 5 years after vaccination. Subjects will be randomized in the primary vaccination phase of the study; no new subjects will be enrolled during the long-term follow-up phase of the study.
Study Details
Timeline
Interventions
One intramuscular dose.
One subcutaneous dose.
One intramuscular dose.