Immunogenicity of Infanrix™ hexa administered at 3, 5 and 11 months of age

Vaccine. 2012 Apr 5;30(17):2710-4. doi: 10.1016/j.vaccine.2012.02.024. Epub 2012 Feb 18.

Abstract

A pooled analysis of data from four vaccination studies conducted in Europe was undertaken to assess the immunogenicity of Infanrix™ hexa (DTPa-HBV-IPV/Hib, GlaxoSmithKline Biologicals) when administered in a total of 702 healthy infants at 3, 5 and 11-12 months of age. One month after dose 2, between 96.3% and 100% of subjects had seroprotective antibodies against diphtheria, tetanus, hepatitis B and poliovirus types 1, 2 and 3; 91.7% against Hib and ≥99.0% were seropositive for each pertussis antigen. One month after the third dose, 98.9-100% of subjects were seroprotected/seropositive for all vaccine antigens. Geometric mean antibody concentrations/titres for each vaccine antigen increased by 6.7-52.9 fold after the third vaccine dose. No serious adverse events in DTPa-HBV-IPV/Hib recipients were vaccine related. Infanrix™ hexa induces an adequate immune response after 2-dose primary plus booster doses when administered according to a 3, 5 and 11 months schedule.

Trial registration: ClinicalTrials.gov NCT01457508 NCT01457547 NCT01457560.

Publication types

  • Clinical Trial, Phase II
  • Clinical Trial, Phase III
  • Clinical Trial, Phase IV
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Bacterial / blood
  • Antibodies, Bacterial / immunology
  • Antibodies, Viral / blood
  • Antibodies, Viral / immunology
  • Diphtheria / immunology
  • Diphtheria / prevention & control
  • Diphtheria-Tetanus-acellular Pertussis Vaccines / administration & dosage*
  • Diphtheria-Tetanus-acellular Pertussis Vaccines / adverse effects
  • Diphtheria-Tetanus-acellular Pertussis Vaccines / immunology*
  • Female
  • Haemophilus Infections / immunology
  • Haemophilus Infections / prevention & control
  • Haemophilus Vaccines / administration & dosage*
  • Haemophilus Vaccines / adverse effects
  • Haemophilus Vaccines / immunology*
  • Hepatitis B / immunology
  • Hepatitis B / prevention & control
  • Humans
  • Infant
  • Male
  • Poliomyelitis / immunology
  • Poliomyelitis / prevention & control
  • Poliovirus Vaccine, Inactivated / administration & dosage*
  • Poliovirus Vaccine, Inactivated / adverse effects
  • Poliovirus Vaccine, Inactivated / immunology*
  • Tetanus / immunology
  • Tetanus / prevention & control
  • Time Factors
  • Vaccines, Combined / administration & dosage
  • Vaccines, Combined / adverse effects
  • Vaccines, Combined / immunology

Substances

  • Antibodies, Bacterial
  • Antibodies, Viral
  • Diphtheria-Tetanus-acellular Pertussis Vaccines
  • Haemophilus Vaccines
  • Poliovirus Vaccine, Inactivated
  • Vaccines, Combined

Associated data

  • ClinicalTrials.gov/NCT01457508
  • ClinicalTrials.gov/NCT01457547
  • ClinicalTrials.gov/NCT01457560