title: Immunogenicity and safety of a pentavalent acellular pertussis combined vaccine including diphtheria, tetanus, inactivated poliovirus and conjugated Haemophilus Influenzae type b polysaccharide for primary vaccination at 2, 3, 4 or 3, 4, 5 months of age in infants in China.
abstract: The aim was to demonstrate the immunogenicity and safety of a DTaP-IPV//PRP-T combined vaccine (Pentaxim(®)) compared to individual vaccines in infants in the People's Republic of China. Infants (N=792) were randomly assigned to receive DTaP-IPV//PRP-T at 2, 3 and 4 months of age (Group A) or 3, 4 and 5 months of age (Group B), or DTaP (Wuhan Institute of Biological Products), PRP-T (Act-Hib(®)) and IPV (Imovax(®) Polio) at 3, 4 and 5 months of age (Group C). Antibody titers were measured pre- and 1 month after the third vaccination; non-inferiority analyses were performed for seroprotection/seroconversion (SP/SC) rates. Safety was assessed 1 month after the primary series. SP/SC rates for the DTaP-IPV//PRP-T vaccine were high and non-inferior to the controls. Reactogenicity was low for each group and no hypotonic hyporesponsive episode or seizure was reported. In conclusion, the DTaP-IPV//PRP-T vaccine was highly immunogenic, non-inferior to the commercially available control vaccines and had a good safety profile for both primary administration schedules.
authors.affiliation: Guanxi Autonomous Region Center for Disease Prevention and Control, China.
authors.forename: Rong Cheng
authors.initials: RC
authors.lastname: Li
authors.forename: Feng Xiang
authors.initials: FX
authors.lastname: Li
authors.forename: Yan Ping
authors.initials: YP
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: Yan Ping
authors.initials: YP
authors.lastname: Zhang
authors.forename: Esteban
authors.initials: E
authors.lastname: Ortiz
mesh_terms: D000367:Age Factors; D000907:Antibodies, Bacterial / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D002681:China; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D007117:Immunization, Secondary / Q000379:methods*; D007223:Infant; D008297:Male; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D014611:Vaccination / Q000379:methods*; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate; C541235:diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine