title: Immunogenicity and reactogenicity of primary immunization with a novel combined Haemophilus influenzae Type b and Neisseria meningitidis Serogroup C-tetanus toxoid conjugate vaccine coadministered with a Diphtheria-tetanus-acellular Pertussis-hepatitis B-inactivated poliovirus vaccine at 2, 4 and 6 months.
abstract: BACKGROUND
  This phase II study evaluated the immunogenicity and reactogenicity of primary vaccination with a novel Hib-MenC conjugate vaccine (GlaxoSmithKline [GSK] Biologicals) coadministered with DTPa-HBV-IPV (GSK Biologicals) at 2, 4 and 6 months.
  
  
  METHODS
  Healthy infants were randomized to receive Hib-MenC coadministered with DTPa-HBV-IPV (N = 117) or MenC-CRM (Wyeth) coadministered with DTPa-HBV-IPV/Hib (GSK Biologicals; N = 120) at 2, 4 and 6 months. Antibody concentrations were measured before vaccination and after doses 2 and 3. Solicited local and general symptoms, unsolicited symptoms and serious adverse events (SAEs) were recorded.
  
  
  RESULTS
  All subjects in the Hib-MenC group had seroprotective titers of anti-PRP antibodies (>or=0.15 microg/mL) and SBA-MenC titers (>or=1:8) 1 month after the third dose. These responses were noninferior to those seen in the control group, in which a 99.1% seroprotection rate was observed for both Hib and MenC. At that time, anti-PRP and SBA-MenC GMTs were significantly higher in the Hib-MenC group (12.8 microg/mL and 2467.1 microg/mL, respectively) than in the control group (3.8 microg/mL and 1833.7 microg/mL). High seroprotection rates were already observed after the second dose of Hib-MenC; 96.4% and 100% of subjects were seroprotected to Hib and MenC, respectively. Immune responses to coadministered antigens were unimpaired; seroprotection/vaccine response rates >or=96.5% were recorded postdose 3 in the Hib-MenC group. No differences in reactogenicity were seen between the 2 study groups.
  
  
  CONCLUSIONS
  Coadministration of a Hib-MenC conjugate vaccine with DTPa-HBV-IPV is well tolerated and immunogenic, and does not impair the immune response to any of the coadministered antigens.
authors.affiliation: Móstoles Hospital, Madrid, Spain.
authors.forename: Juan C
authors.initials: JC
authors.lastname: Tejedor
authors.forename: Manuel
authors.initials: M
authors.lastname: Moro
authors.forename: Jesús
authors.initials: J
authors.lastname: Ruiz-Contreras
authors.forename: Javier
authors.initials: J
authors.lastname: Castro
authors.forename: José Antonio
authors.initials: JA
authors.lastname: Gómez-Campderá
authors.forename: María Luisa
authors.initials: ML
authors.lastname: Navarro
authors.forename: José Manuel
authors.initials: JM
authors.lastname: Merino
authors.forename: Ana
authors.initials: A
authors.lastname: Martín-Ancel
authors.forename: Joan
authors.initials: J
authors.lastname: Roca
authors.forename: Manuel
authors.initials: M
authors.lastname: García-Del-Rí
authors.forename: Antonio
authors.initials: A
authors.lastname: Jurado
authors.forename: Francisco Javier
authors.initials: FJ
authors.lastname: Díez-Delgado
authors.forename: Félix
authors.initials: F
authors.lastname: Omeñaca
authors.forename: José
authors.initials: J
authors.lastname: García-Sicilia
authors.forename: Reyes
authors.initials: R
authors.lastname: Boceta
authors.forename: Pilar
authors.initials: P
authors.lastname: García-Corbeira
authors.forename: Alix
authors.initials: A
authors.lastname: Collard
authors.forename: Dominique
authors.initials: D
authors.lastname: Boutriau
authors.forename: Lode
authors.initials: L
authors.lastname: Schuerman
authors.forename: Jeanne-Marie
authors.initials: JM
authors.lastname: Jacquet
mesh_terms: D016667:Bacterial Capsules; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D017325:Hepatitis B Vaccines; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D038542:Neisseria meningitidis, Serogroup C / Q000276:immunology*; 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; D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine; D017325:Hepatitis B Vaccines; D022401:Meningococcal Vaccines; D011054:Poliovirus Vaccine, Inactivated; D011135:Polysaccharides, Bacterial; D017778:Vaccines, Combined