title: [Immunogenicity and safety of DTaP-IPV//PRP-T combined vaccine in infants in China].
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Guangxi Autonomous Region Center for Disease Control and Prevention, Nanning 530023, China.
authors.forename: Yan-ping
authors.initials: YP
authors.lastname: Li
authors.forename: Feng-xiang
authors.initials: FX
authors.lastname: Li
authors.forename: Qi-ming
authors.initials: QM
authors.lastname: Hou
authors.forename: Chang-gui
authors.initials: CG
authors.lastname: Li
authors.forename: Ya-nan
authors.initials: YN
authors.lastname: Li
authors.forename: Fu-sheng
authors.initials: FS
authors.lastname: Chen
authors.forename: Xue-zhong
authors.initials: XZ
authors.lastname: Hu
authors.forename: Wen-bin
authors.initials: WB
authors.lastname: Su
authors.forename: Shu-min
authors.initials: SM
authors.lastname: Zhang
authors.forename: Han-hua
authors.initials: HH
authors.lastname: Fang
authors.forename: Qiang
authors.initials: Q
authors.lastname: Ye
authors.forename: Tian-de
authors.initials: TD
authors.lastname: Zeng
authors.forename: Tao-xuan
authors.initials: TX
authors.lastname: Liu
authors.forename: Xiu-bi
authors.initials: XB
authors.lastname: Li
authors.forename: Yun-neng
authors.initials: YN
authors.lastname: Huang
authors.forename: Man-ling
authors.initials: ML
authors.lastname: Deng
authors.forename: Rong-cheng
authors.initials: RC
authors.lastname: Li
authors.forename: Yan-ping
authors.initials: YP
authors.lastname: Zhang
authors.forename: Ortiz
authors.initials: O
authors.lastname: Esteban
mesh_terms: D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000276:immunology; D005260:Female; D018073:Haemophilus Vaccines / Q000009:adverse effects / Q000276:immunology; D006801:Humans; D007117:Immunization, Secondary; D007223:Infant; D008297:Male; D011054:Poliovirus Vaccine, Inactivated / Q000009:adverse effects / Q000276:immunology; D018074:Vaccines, Conjugate / Q000009:adverse effects / Q000276:immunology
chemical_list: D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D018073:Haemophilus Vaccines; D011054:Poliovirus Vaccine, Inactivated; D018074:Vaccines, Conjugate