title: Co-administration of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine does not interfere with the immune response to antigens contained in infant vaccines routinely used in the United States.
abstract: An investigational combined Haemophilus influenzae type b (Hib) and Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY-TT) has been developed to protect infants from invasive disease caused by Hib and these meningococcal serogroups without adding injections to the immunization schedule. Incorporation of this novel vaccine into the US vaccination schedule will require demonstration of a lack of immunologic interference with other routine pediatric vaccines. This study assessed the immune response to 7-valent pneumococcal conjugate vaccine (PCV7) and combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus vaccine (DTaP-HepB-IPV) when separately co-administered with HibMenCY-TT as compared to a US-licensed H. influenzae type b tetanus toxoid conjugate vaccine (Hib-TT) at 2, 4, 6 (N=606) and 12-15 months of age (N=366). HibMenCY-TT was non-inferior to Hib-TT in terms of antibody responses to all Streptococcus pneumoniae serotypes contained in PCV7 and the diphtheria, tetanus, pertussis, hepatitis B and poliovirus antigens contained in DTaP-HepB-IPV one month after the third vaccine dose, and the anti-tetanus geometric mean antibody concentration (GMC) was significantly higher in the HibMenCY-TT group than in the Hib-TT group. In an exploratory analysis, no significant differences in the proportion of subjects with anti-pneumococcal antibody concentrations ≥0.2 µg/ml or anti-pneumococcal GMC were seen between the two groups after the fourth vaccine dose. A schedule of HibMenCY-TT given concomitantly with PCV7 and DTaP-HepB-IPV would be expected to protect infants against all of the targeted diseases.
authors.affiliation: University of Louisville, Louisville, KY, USA. gsmars01@louisville.edu
authors.forename: Gary S
authors.initials: GS
authors.lastname: Marshall
authors.forename: Colin D
authors.initials: CD
authors.lastname: Marchant
authors.forename: Mark
authors.initials: M
authors.lastname: Blatter
authors.forename: Leonard R
authors.initials: LR
authors.lastname: Friedland
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Aris
authors.forename: Jacqueline M
authors.initials: JM
authors.lastname: Miller
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000276:immunology; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000276:immunology*; D019741:Haemophilus influenzae type b / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000276:immunology; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D006801:Humans; D007223:Infant; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000276:immunology*; D038542:Neisseria meningitidis, Serogroup C / Q000276:immunology*; D010567:Pertussis Vaccine / Q000276:immunology; D022242:Pneumococcal Vaccines / Q000276:immunology; D011054:Poliovirus Vaccine, Inactivated / Q000276:immunology; D016037:Single-Blind Method; D013745:Tetanus Toxoid / Q000008:administration & dosage / Q000276:immunology*; D017778:Vaccines, Combined / Q000276:immunology; D018074:Vaccines, Conjugate / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D022401:Meningococcal Vaccines; D010567:Pertussis Vaccine; D022242:Pneumococcal Vaccines; D011054:Poliovirus Vaccine, Inactivated; D013745:Tetanus Toxoid; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate; C541235:diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine