Immunogenicity and safety of fully liquid DTaP₅-IPV-Hib compared with DTaP₃-IPV/Hib when both coadministered with a heptavalent pneumococcal conjugate vaccine (PCV7) at 2, 3, 4, and 12 to 18 months of age: a phase III, single-blind, randomised, controlled, multicentre study

Vaccine. 2011 Oct 6;29(43):7370-8. doi: 10.1016/j.vaccine.2011.07.078. Epub 2011 Jul 30.

Abstract

This study compared immunogenicity and safety of DTaP(5)-IPV-Hib to DTaP(3)-IPV/Hib coadministered with PCV7 at 2, 3, and 4 months (primary series) and a fourth-dose booster at 12-18 months of age. Seroprotection rates for DTaP(5)-IPV-Hib were high (noninferior to DTaP(3)-IPV/Hib for the primary series) for antigens common to both vaccines and PCV7 antigens. Geometric mean concentration (GMC) for Hib antibodies were higher in the DTaP(5)-IPV-Hib group than the DTaP(3)-IPV/Hib group after the primary series and booster dose; GMCs or titers for other antigens were generally similar between groups after the primary series and booster dose. Safety profiles were similar between groups.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Antibodies, Bacterial / biosynthesis
  • Antibodies, Bacterial / immunology
  • Diphtheria-Tetanus-acellular Pertussis Vaccines* / administration & dosage
  • Diphtheria-Tetanus-acellular Pertussis Vaccines* / adverse effects
  • Diphtheria-Tetanus-acellular Pertussis Vaccines* / immunology
  • Female
  • Haemophilus Vaccines* / administration & dosage
  • Haemophilus Vaccines* / adverse effects
  • Haemophilus Vaccines* / immunology
  • Heptavalent Pneumococcal Conjugate Vaccine
  • Humans
  • Immunization Schedule
  • Infant
  • Male
  • Pneumococcal Vaccines* / administration & dosage
  • Pneumococcal Vaccines* / adverse effects
  • Pneumococcal Vaccines* / immunology
  • Poliovirus Vaccines* / administration & dosage
  • Poliovirus Vaccines* / adverse effects
  • Poliovirus Vaccines* / immunology
  • Single-Blind Method
  • Vaccines, Combined* / administration & dosage
  • Vaccines, Combined* / adverse effects
  • Vaccines, Combined* / immunology
  • Vaccines, Conjugate / administration & dosage
  • Vaccines, Conjugate / adverse effects
  • Vaccines, Conjugate / immunology

Substances

  • Antibodies, Bacterial
  • Diphtheria-Tetanus-acellular Pertussis Vaccines
  • Haemophilus Vaccines
  • Heptavalent Pneumococcal Conjugate Vaccine
  • Pneumococcal Vaccines
  • Poliovirus Vaccines
  • Vaccines, Combined
  • Vaccines, Conjugate