title: Immunogenicity and reactogenicity of primary immunization with a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Haemophilus influenzae type B vaccine coadministered with two doses of a meningococcal C-tetanus toxoid conjugate vaccine.
abstract: BACKGROUND
  This study evaluated the concurrent use of meningococcal C tetanus conjugate (MenC-TT) vaccine (NeisVac-C) with DTaP-based combinations, according to 2 vaccination schedules, one of which included hepatitis B vaccination at birth (Trial DTaP-HBV-IPV/Hib-097).
  
  
  METHODS
  Healthy infants were randomized to receive either DTaP-HBV-IPV/Hib (Infanrix hexa) at 2, 4, and 6 months (N = 115) or HBV at birth followed by DTaP-HBV-IPV/Hib at 2 and 6 months and DTaP-IPV/Hib (Infanrix-IPV Hib) at 4 months (N = 115). In both groups 2 doses of MenC-TT conjugate were coadministered at 2 and 4 months, and compared with 3 doses of MenC-CRM197 conjugate (Meningitec) coadministered at 2, 4, and 6 months with DTaP-HBV-IPV/Hib (N = 120). Antibody concentrations were measured at 2, 6 and 7 months. Solicited local and general symptoms, unsolicited symptoms, and serious adverse events (SAEs) were recorded.
  
  
  RESULTS
  All MenC-TT recipients had seroprotective concentrations of anti-PRP antibodies (> or = 0.15 microg/mL) 1 month after the third vaccine dose and all had SBA-MenC titers > or = 1:8 after the second dose of MenC-TT. These responses were noninferior to those seen after 3 doses of DTaP-HBV-IPV/Hib and MenC-CRM. Anti-PRP antibody GMCs were significantly higher in MenC-TT than MenC-CRM vaccinees (7.9, 7.3, 3.8 microg/mL, respectively). Immune responses to all other coadministered antigens were unimpaired, with seroprotection/seropositivity rates > or = 98.1% in MenC-TT vaccinees. All schedules studied were well tolerated, with no differences in reactogenicity between the study groups.
  
  
  CONCLUSIONS
  Coadministration of DTaP-HBV-IPV/Hib or DTaP-IPV/Hib with 2 doses of MenC-TT conjugate vaccine is safe, well tolerated, and immunogenic, with no impairment of the response to 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: Jesus
authors.initials: J
authors.lastname: Ruiz-Contreras
authors.forename: Javier
authors.initials: J
authors.lastname: Castro
authors.forename: Jose A
authors.initials: JA
authors.lastname: Gómez-Campderá
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: Navarro
authors.forename: Jose 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-Río
authors.forename: Antonio
authors.initials: A
authors.lastname: Jurado
authors.forename: Francisco Javier
authors.initials: FJ
authors.lastname: Díez-Delgado
authors.forename: Felix
authors.initials: F
authors.lastname: Omeñaca
authors.forename: Jose
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: Jeanne-Marie
authors.initials: JM
authors.lastname: Jacquet
authors.forename: Alix
authors.initials: A
authors.lastname: Collard
authors.forename: Lode
authors.initials: L
authors.lastname: Schuerman
mesh_terms: D000704:Analysis of Variance; D004165:Diphtheria / Q000517:prevention & control; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000276:immunology*; D004306:Dose-Response Relationship, Immunologic; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000276:immunology*; D006509:Hepatitis B / Q000517:prevention & control; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000276:immunology*; D011051:Poliomyelitis / Q000517:prevention & control; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000276:immunology*; D013030:Spain; D013742:Tetanus / Q000517:prevention & control; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D022401:Meningococcal Vaccines; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate; C122182:diphtheria-tetanus-acellular pertussis-Hib-hepatitis B vaccine