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Pediatr Infect Dis J. 2012 Feb 1. [Epub ahead of print]

Identification of Antigen and Adjuvant Doses Resulting in Optimal Immunogenicity and Antibody Persistence up to One Year After Immunization with a Pandemic A/H1N1 Influenza Vaccine in Children 3 to < 9 Years of Age.

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  • 11Nassim and Associates, Pediatric Medicine, New Albany Indiana, USA 2J. Lewis Research, Inc. Foothill Family Clinic South and Foothill Family Clinic, Salt Lake City, UT, USA 3Novartis Vaccine and Diagnostics, Cambridge, MA, USA.

Abstract

BACKGROUND:: In the development of pediatric A/H1N1 influenza vaccines this study was performed to identify antigen and adjuvant doses providing optimal immunogenicity and antibody persistence to ensure long-term immunity following immunization with an adjuvanted A/H1N1 vaccine in children 3 to <9 years of age. METHODS:: Healthy children (N=1357) were immunized with one of eight investigational vaccine formulations ranging in antigen (3.75 μg to 30 μg) and MF59® adjuvant (Novartis Vaccines, Marburg, Germany; 0%, 50% and 100% of standard dose). Each participant received two vaccine doses given three weeks apart. Immunogenicity was analyzed by hemagglutination inhibition assay in sera drawn three, four and six weeks after first vaccination. Long-term antibody persistence was assessed six and twelve months after immunization. Vaccine safety was monitored throughout the study. RESULTS:: All MF59-adjuvanted vaccines were well tolerated and highly immunogenic, with adjuvanted formulations inducing antibody titers statistically superior to those of the non-adjuvanted vaccines. Each MF59-adjuvanted vaccine met all the U.S. and European licensure criteria for influenza vaccines three weeks after the administration of a single dose; all non-adjuvanted formulations failed to meet licensure criteria at this time point. Antibody titers in response to a single vaccination with 7.5 μg antigen and a full dose of MF59 continued to meet all U.S. and European licensure criteria up to one year after immunization. CONCLUSION:: A single dose of vaccine containing 7.5 μg A/California/7/2009 (H1N1) antigen and a full dose of MF59 adjuvant was found to be optimal for children 3 to <9 years of age.

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