title: Immunogenicity and reactogenicity of a novel hexavalent DTPa-HBV-IPV/Hib vaccine compared to separate concomitant injections of DTPa-IPV/Hib and HBV vaccines, when administered according to a 3, 5 and 11 month vaccination schedule.
abstract: In an open randomised trial, 312 eligible infants were enrolled to receive either a single injection of the hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated polio/ Haemophilus influenzae b (DTPa-HBV-IPV/Hib) vaccine, or concomitant injections of commercial DTPa-IPV/Hib and HBV vaccines (comparator). Vaccines were administered at 3, 5 and 11 months of age. The statistical approach for non-inferiority showed that the DTPa-HBV-IPV/Hib vaccine was at least as immunogenic as the comparator vaccines in terms of immunogenicity of all antigens 1 month after the 2nd dose. Non-inferiority criteria were also met immediately before and 1 month after the 3rd dose for all antigens except poliovirus type 3 prior to the 3rd dose. The majority of subjects were seroprotected against diphtheria, tetanus, polyribosyl-ribitol-phosphate, hepatitis B and poliovirus after the 2nd dose and maintained seroprotective antibody levels until the 3rd dose. A marked difference was observed in anti-HBs antibody geometric mean antibody concentrations (GMCs) at 1 month after the 2nd dose (higher GMCs in DTPa-HBV-IPV/Hib group). Reactogenicity (incidence of solicited local and general symptoms) was similar between the two study groups and no vaccine-related serious adverse events occurred.
  
  
  CONCLUSIONS
  the new diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated polio/ Haemophilus influenzae b vaccine administered at 3, 5 and 11 months of age was safe and at least as immunogenic as the comparator vaccines thus providing an effective and more comfortable option for this infant vaccination schedule.
authors.affiliation: State Institute of Public Health, Hviezdoslavova 19, 97556 Banská Bystrica, Slovakia. Avdicova@suhe.siph.sk
authors.forename: Mária
authors.initials: M
authors.lastname: Avdicová
authors.forename: Viktor
authors.initials: V
authors.lastname: Prikazský
authors.forename: Henrieta
authors.initials: H
authors.lastname: Hudecková
authors.forename: Lode
authors.initials: L
authors.lastname: Schuerman
authors.forename: Paul
authors.initials: P
authors.lastname: Willems
mesh_terms: D016667:Bacterial Capsules; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; 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; D007115:Immunization Schedule; D007223:Infant; D011054:Poliovirus Vaccine, Inactivated; D011135:Polysaccharides, Bacterial / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D017778:Vaccines, Combined / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology
chemical_list: C451839:DTPa-HBV-IPV combined vaccine; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine; D017325:Hepatitis B Vaccines; D011054:Poliovirus Vaccine, Inactivated; D011135:Polysaccharides, Bacterial; D017778:Vaccines, Combined