Combined immunogenicity data for a new DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim) following primary series administration at 2, 4, 6 months of age in Latin America

Vaccine. 2013 Feb 18;31(9):1255-8. doi: 10.1016/j.vaccine.2012.11.087. Epub 2012 Dec 12.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Bacterial / blood*
  • Antibodies, Viral / blood*
  • Argentina
  • Diphtheria-Tetanus-Pertussis Vaccine / administration & dosage*
  • Diphtheria-Tetanus-Pertussis Vaccine / immunology*
  • Haemophilus Vaccines / administration & dosage*
  • Haemophilus Vaccines / immunology*
  • Hepatitis B Vaccines / administration & dosage*
  • Hepatitis B Vaccines / immunology*
  • Humans
  • Infant
  • Mexico
  • Peru
  • Poliovirus Vaccine, Inactivated / administration & dosage*
  • Poliovirus Vaccine, Inactivated / immunology*
  • Vaccines, Combined / administration & dosage
  • Vaccines, Combined / immunology

Substances

  • Antibodies, Bacterial
  • Antibodies, Viral
  • Diphtheria-Tetanus-Pertussis Vaccine
  • Haemophilus Vaccines
  • Hepatitis B Vaccines
  • Poliovirus Vaccine, Inactivated
  • Vaccines, Combined
  • diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine