Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014

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.

Timeline

Start

2008-02-13

Primary completion

2009-07-31

Completion

2009-09-17

Publications

• Leonardi M, Latiolais T, Sarpong K, Simon M, Twiggs J, Lei P, Rinderknecht S, Blatter M, Bianco V, Baine Y, Friedland LR, Baccarini C, Miller JM. Immunogenicity and reactogenicity of Infanrix when co-administered with meningococcal MenACWY-TT conjugate vaccine in toddlers primed with MenHibrix and Pediarix. Vaccine. 2015 Feb 11;33(7):924-32. doi: 10.1016/j.vaccine.2014.09.064. Epub 2014 Oct 8.
• Leonardi M, Latiolais T, Sarpong K, Simon M, Twiggs J, Lei P, Rinderknecht S, Blatter M, Bianco V, Baine Y, Friedland LR, Miller JM. Quadrivalent meningococcal (MenACWY-TT) conjugate vaccine or a fourth dose of H. influenzae-N. meningitidis C/Y conjugate vaccine (HibMenCY-TT) is immunogenic in toddlers who previously received three doses of HibMenCY-TT in infancy. Vaccine. 2015 Feb 11;33(7):933-41. doi: 10.1016/j.vaccine.2014.08.027. Epub 2014 Aug 21.

Drugs

Indications