[Immunogenicity and safety of DTaP-IPV//PRP-T combined vaccine in infants in China]

Zhonghua Liu Xing Bing Xue Za Zhi. 2011 Aug;32(8):808-15.
[Article in Chinese]


Objective: The aim of this study was to demonstrate the immunogenicity and safety of diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccine (DTaP-IPV//PRP-T) combined vaccine compared with commercially available DTaP (diphtheria, tetanus and pertussis), Haemophilus influenzae type b (Hib), tetanus conjugate and IPV monovalent vaccine.

Methods: Subjects were randomly divided into three groups, Group A and Group B were DTaP-IPV//PRP-T combined vaccine (PENTAXIM(TM)) vaccinated at 2, 3, 4 months of age or 3, 4, 5 months of age respectively; Group C was commercially available DTaP. Hib tetanus conjugate (Act-HIB(TM)) and IPV (IMOVAX PolioTM(TM)) vaccines vaccinated at 3, 4, 5 months of age. All groups received booster dose at 18 to 20 months of age, with antibody titers tested. Non-inferiority analysis was demonstrated in terms of seroprotection/seroconversion rates between Group A, Group B respectively and Group C. Safety information was collected after each vaccination to assess the safety of investigational vaccines.

Results: The non-inferiority of DTaP-IPV//PRP-T combined vaccine vaccinated at 2, 3, 4 or 3, 4, 5 months of age versus DTaP, Hib tetanus conjugate and IPV vaccine was demonstrated for all vaccine antigens in both primary and booster phases in terms of seroprotection/seroconversion rates. DTaP-IPV//PRP-T combined vaccine was well tolerated. The rate of solicited/unsolicited severe adverse reactions was very low and similar to the control vaccines.

Conclusion: DTaP-IPV//PRP-T combined vaccine was highly immunogenic with good safety profile in Chinese infants, which was comparable to the commercially available control vaccines.

Publication types

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

MeSH terms

  • Diphtheria-Tetanus-acellular Pertussis Vaccines* / immunology
  • Female
  • Haemophilus Vaccines* / adverse effects
  • Haemophilus Vaccines* / immunology
  • Humans
  • Immunization, Secondary
  • Infant
  • Male
  • Poliovirus Vaccine, Inactivated* / adverse effects
  • Poliovirus Vaccine, Inactivated* / immunology
  • Vaccines, Conjugate* / adverse effects
  • Vaccines, Conjugate* / immunology


  • Diphtheria-Tetanus-acellular Pertussis Vaccines
  • Haemophilus Vaccines
  • Poliovirus Vaccine, Inactivated
  • Vaccines, Conjugate