Abstract
The immunogenicity of a primary series of a new, fully liquid DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim), administered at 2, 4, 6 months of age in four clinical studies is reviewed. Immunogenicity data at 1 month after the third vaccination were assessed and pooled from a total of 1270 participants (per-protocol population) in four randomized clinical trials in Argentina, Mexico, and Peru. Hepatitis B vaccine was not administered at birth. All seroprotection (D, T, polio-1, -2, -3, Hep B, PRP-T [Hib]), seroconversion (PT and FHA), and vaccine response (PT and FHA) data were high, and were similar to licensed comparators (pooled SP, SC, and VR rates were 97.1-100%, 96.0-97.0%, and 99.7-99.9%, respectively). These data show the good immunogenicity of this new hexavalent vaccine that can provide the opportunity to increase global compliance to complex pediatric vaccination schedules.
Copyright © 2013. Published by Elsevier Ltd.
Publication types
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Antibodies, Bacterial / blood*
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Antibodies, Viral / blood*
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Argentina
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Diphtheria-Tetanus-Pertussis Vaccine / administration & dosage*
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Diphtheria-Tetanus-Pertussis Vaccine / immunology*
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Haemophilus Vaccines / administration & dosage*
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Haemophilus Vaccines / immunology*
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Hepatitis B Vaccines / administration & dosage*
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Hepatitis B Vaccines / immunology*
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Humans
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Infant
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Mexico
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Peru
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Poliovirus Vaccine, Inactivated / administration & dosage*
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Poliovirus Vaccine, Inactivated / immunology*
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Vaccines, Combined / administration & dosage
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Vaccines, Combined / immunology
Substances
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Antibodies, Bacterial
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Antibodies, Viral
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Diphtheria-Tetanus-Pertussis Vaccine
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Haemophilus Vaccines
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Hepatitis B Vaccines
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Poliovirus Vaccine, Inactivated
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Vaccines, Combined
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diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine