Infections, Meningococcal Clinical Trial
Official title:
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.
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.
The purpose of this study is to evaluate the titer of antibody for serogroups A, C, Y and
W-135 and the safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given
to toddlers who were primed with GSK Biological's Hib-meningococcal vaccine 792014. In
addition, this study will provide immunogenicity and safety data on the co-administration of
Infanrix with meningococcal vaccine 134612 as compared to Infanrix administered alone.
Depending on the group the subject is assigned to, one or two blood samples will be taken out
of the subject's arm during the study.
The protocol posting has been updated following a protocol amendment.
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Phase 2 |