title: Phase II and III Clinical Studies of Diphtheria-Tetanus-Acellular Pertussis Vaccine Containing Inactivated Polio Vaccine Derived from Sabin Strains (DTaP-sIPV).
abstract: BACKGROUND
  Phase II and III clinical studies were conducted to evaluate immunogenicity and safety of a novel DTaP-IPV vaccine consisting of Sabin inactivated poliovirus vaccine (sIPV) and diphtheria-tetanus-acellular pertussis vaccine (DTaP).
  
  
  METHODS
  A Phase II study was conducted in 104 healthy infants using Formulation H of the DTaP-sIPV vaccine containing high-dose sIPV (3, 100, and 100 D-antigen units for types 1, 2, and 3, respectively), and Formulations M and L, containing half and one-fourth of the sIPV in Formulation H, respectively. Each formulation was administered 3 times for primary immunization and once for booster immunization. A Phase III study was conducted in 342 healthy infants who received either Formulation M + oral polio vaccine (OPV) placebo or DTaP + OPV. The OPV or OPV placebo was orally administered twice between primary and booster immunizations.
  
  
  RESULTS
  Formulation M was selected as the optimum dose. In the Phase III study, the seropositive rate was 100% for all Sabin strains after primary immunization, and the neutralizing antibody titer after booster immunization was higher than in the control group (DTaP + OPV). All adverse reactions were clinically acceptable.
  
  
  CONCLUSIONS
  DTaP-sIPV was shown to be a safe and immunogenic vaccine.
  
  
  BACKGROUND
  JapicCTI-121902 for Phase II study, JapicCTI-101075 for Phase III study (http://www.clinicaltrials.jp/user/cte_main.jsp).
authors.affiliation: Fukuoka National Hospital, Fukuoka, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Okada
authors.forename: Chiaki
authors.initials: C
authors.lastname: Miyazaki
authors.forename: Yoichiro
authors.initials: Y
authors.lastname: Kino
authors.forename: Takao
authors.initials: T
authors.lastname: Ozaki
authors.forename: Mizuo
authors.initials: M
authors.lastname: Hirose
authors.forename: Kohji
authors.initials: K
authors.lastname: Ueda
mesh_terms: D000907:Antibodies, Bacterial / Q000276:immunology; D000914:Antibodies, Viral / Q000276:immunology; D000917:Antibody Formation / Q000276:immunology; D004165:Diphtheria / Q000276:immunology / Q000517:prevention & control; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage* / Q000276:immunology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007117:Immunization, Secondary / Q000379:methods; D007223:Infant; D008297:Male; D011051:Poliomyelitis / Q000276:immunology / Q000517:prevention & control; D017955:Poliovirus / Q000276:immunology; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage* / Q000276:immunology; D011055:Poliovirus Vaccine, Oral / Q000008:administration & dosage* / Q000276:immunology; D013742:Tetanus / Q000276:immunology / Q000517:prevention & control; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000276:immunology; D014917:Whooping Cough / Q000276:immunology / Q000517:prevention & control
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D011054:Poliovirus Vaccine, Inactivated; D011055:Poliovirus Vaccine, Oral; D017778:Vaccines, Combined
keywords: DTaP; IPV; Sabin strain; clinical study; combination vaccine