Safety and immunogenicity of a pentavalent combination vaccine (diphtheria, tetanus, acellular pertussis, polio, and haemophilus influenzae type B conjugate) when administered as a fourth dose at 15 to 18 months of age

Hum Vaccin. 2005 Sep-Oct;1(5):180-6. doi: 10.4161/hv.1.5.2079. Epub 2005 Sep 29.

Abstract

A DTaP-IPV//PRP-T combination vaccine (Pentacel) has been universally used in Canada to provide immunization against diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae type b with single injections at 2, 4, 6 and 18 months of age. This randomized, multicenter study was conducted to evaluate administration of a fourth dose of DTaP-IPV//PRP-T at 15 to 18 months of age, similar to the US immunization schedule. Participants who had received three doses of DTaP-IPV//PRP-T by 8 months of age were enrolled at 12 months and randomized to receive a fourth dose at 15, 16, 17 or 18 months. Antibody levels for each vaccine antigen were measured prior to and four weeks following booster vaccination. Overall, 1782 subjects were immunized and monitored for adverse events, and 735 were evaluated for immune responses. Preimmunization antibody levels differed minimally by age, for all antigens. The immune responses elicited by DTaP-IPV//PRP-T were comparable between participants vaccinated at 15 or 16 months and those vaccinated at 17 or 18 months, as demonstrated by specific antibody geometric mean titers, seroprotection/seroresponse rates, and reverse cumulative distribution curves. The fourth dose was well tolerated in all age groups. Toddlers at 15, 16, 17 or 18 months of age are equally suitable recipients for booster immunization with the DTaP-IPV//PRP-T vaccine.

Publication types

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

MeSH terms

  • Age Distribution
  • Age Factors
  • Antibody Formation / drug effects
  • Antibody Formation / immunology
  • Diphtheria-Tetanus-acellular Pertussis Vaccines / administration & dosage*
  • Diphtheria-Tetanus-acellular Pertussis Vaccines / adverse effects
  • Diphtheria-Tetanus-acellular Pertussis Vaccines / immunology
  • Enzyme-Linked Immunosorbent Assay / methods
  • Female
  • Follow-Up Studies
  • Haemophilus Vaccines / administration & dosage*
  • Haemophilus Vaccines / adverse effects
  • Haemophilus Vaccines / immunology
  • Hepatitis B Vaccines / administration & dosage*
  • Hepatitis B Vaccines / adverse effects
  • Hepatitis B Vaccines / immunology
  • Humans
  • Immunization Schedule*
  • Immunocompetence / drug effects
  • Immunocompetence / immunology
  • Infant
  • Injections, Intramuscular
  • Male
  • Time Factors
  • Vaccines, Combined / administration & dosage
  • Vaccines, Combined / adverse effects
  • Vaccines, Combined / immunology

Substances

  • COMVAX
  • Diphtheria-Tetanus-acellular Pertussis Vaccines
  • Haemophilus Vaccines
  • Hepatitis B Vaccines
  • Vaccines, Combined