title: Immunogenicity and safety of a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus vaccine (DTaP-IPV) compared to separate administration of standalone DTaP and IPV vaccines: a randomized, controlled study in infants in the Republic of Korea.
abstract: This randomized trial enrolled 442 infants in the Republic of Korea to assess the immunogenicity and safety of a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus vaccine (DTaP-IPV; Tetraxim™) for primary vaccination at 2, 4 and 6 months of age compared with DTaP and IPV vaccines given separately. Immunogenicity was high in both groups; seroprotection and seroconversion rates of the combined vaccine (Group A) were non-inferior to the control vaccines (Group B). All subjects were seroprotected against poliovirus types 1, 2 and 3 (≥ 81/dil) and anti-diphtheria (≥ 0.01 IU/mL); 99.0% were seroprotected against tetanus (≥ 0.1 IU/mL). At least 93.6% had anti-diphtheria antibody titers ≥ 0.1 IU/mL. Anti-pertussis toxoid (PT) and anti-filamentous haemagglutinin (FHA) seroconversion (≥ 4-fold increase in antibody titer) rates were 96.6% and 94.4% for Group A, 92.2% and 78.4% for Group B. Most solicited reactions occurred within 4 days of vaccination, resolved within 3 days and were mild. Severe solicited reactions occurred after ≤ 0.5% of doses in Group A and ≤ 0.9% in Group B. No withdrawals occurred because of adverse events. The DTaP-IPV combined vaccine given at 2, 4, and 6 months of age was well tolerated; immunogenicity was similar to the control vaccines.
authors.affiliation: Incheon St. Mary's Hospital, The Catholic University of Korea, Incheon, Republic of Korea.
authors.forename: Soo Young
authors.initials: SY
authors.lastname: Lee
authors.forename: Hui Sung
authors.initials: HS
authors.lastname: Hwang
authors.forename: Jong Hyun
authors.initials: JH
authors.lastname: Kim
authors.forename: Hyun Hee
authors.initials: HH
authors.lastname: Kim
authors.forename: Hyun Seung
authors.initials: HS
authors.lastname: Lee
authors.forename: Eun Hee
authors.initials: EH
authors.lastname: Chung
authors.forename: Su Eun
authors.initials: SE
authors.lastname: Park
authors.forename: Sang Hyuk
authors.initials: SH
authors.lastname: Ma
authors.forename: Jin Keun
authors.initials: JK
authors.lastname: Chang
authors.forename: Fabrice
authors.initials: F
authors.lastname: Guitton
authors.forename: Esteban
authors.initials: E
authors.lastname: Ortiz
authors.forename: Jin Han
authors.initials: JH
authors.lastname: Kang
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D004165:Diphtheria / Q000517:prevention & control; D004168:Diphtheria Toxoid / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007117:Immunization, Secondary; D007223:Infant; D008297:Male; D010567:Pertussis Vaccine / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D011051:Poliomyelitis / Q000517:prevention & control; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D056910:Republic of Korea; D013742:Tetanus / Q000517:prevention & control; D013745:Tetanus Toxoid / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014917:Whooping Cough / Q000517:prevention & control
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; C051021:DTPP vaccine; D004168:Diphtheria Toxoid; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D010567:Pertussis Vaccine; D011054:Poliovirus Vaccine, Inactivated; D013745:Tetanus Toxoid; D017778:Vaccines, Combined