title: Safety and immunogenicity of a toddler dose following an infant series of a hexavalent diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b, hepatitis B vaccine administered concurrently or at separate visits with a heptavalent pneumococcal conjugate vaccine.
abstract: BACKGROUND
  Combination diphtheria-tetanus-5 component acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine (DTaP5-IPV-Hib-HepB) administered either concurrently with 7-valent pneumococcal conjugate vaccine (PCV7) or 1 month apart was generally safe and immunogenic at 2, 4 and 6 months of age. This study examined the effects of a booster dose at age 15 months.
  
  
  METHODS
  Participants were randomized to DTaP5-IPV-Hib-HepB plus PCV7, DTaP5-IPV-Hib-HepB with PCV7 administered 1 month later or a pentavalent DTaP5-IPV/Hib plus HepB plus PCV7 at 15 months of age in a randomized, open-label, phase IIb clinical trial. Immunogenicity endpoints were rates of seroresponse to pertussis toxoid, filamentous hemagglutinin, pertactin and fimbriae types 2 and 3; rates of seroprotection against (Hib) polyribosylribitol phosphate capsular polysaccharide, hepatitis B surface antigen, diphtheria toxoid, tetanus toxoid and poliovirus types 1, 2 and 3; and geometric mean titers to all vaccine antigens. Safety endpoints included solicited injection-site reactions and systemic and serious adverse events.
  
  
  RESULTS
  Seroresponse/seroprotection rates for all antigens exceeded prespecified criteria in both groups that received the hexavalent DTaP5-IPV-Hib-HepB; in the group that received the currently licensed pentavalent vaccine, seroresponse/seroprotection rates exceeded the criteria for all antigens except filamentous hemagglutinin. Seroresponse rates were ≥88.9% for pertussis antigens and seroprotection rates against polyribosylribitol phosphate capsular polysaccharide, hepatitis B surface antigen, diphtheria toxoid, tetanus toxoid and poliovirus antigens were ≥95.1% in recipients of DTaP5-IPV-Hib-HepB.
  
  
  CONCLUSIONS
  DTaP5-IPV-Hib-HepB administered concomitantly with PCV7 or 1 month apart at 15 months of age following the infant series was well-tolerated and elicited antibody responses to all vaccine antigens, with no significant interference from concomitant PCV7 administration (clinicaltrials.gov registration number NCT00362427).
authors.affiliation: From the *Canadian Center for Vaccinology, IWK Health Centre and Dalhousie University, Halifax, NS; †CHU Sainte Justine, University of Montreal, Montreal, QC; ‡CHUQ, Beauport, QC; §Westcoast Clinical Research, Coquitlam, BC; ¶Children's Hospital of Eastern Ontario, Ottawa, ON; ‖TASC Research, Surrey, BC; **Montreal Children's Hospital, Montreal, QC; ††University of Manitoba, Winnipeg, MB, Canada; ‡‡Merck Research Labs, Upper Gwynedd, PA; and §§Sanofi Pasteur Limited, Toronto, ON, Canada.
authors.forename: Scott A
authors.initials: SA
authors.lastname: Halperin
authors.forename: Bruce
authors.initials: B
authors.lastname: Tapiéro
authors.forename: Marc
authors.initials: M
authors.lastname: Dionne
authors.forename: William
authors.initials: W
authors.lastname: Meekison
authors.forename: Francisco
authors.initials: F
authors.lastname: Diaz-Mitoma
authors.forename: Paul
authors.initials: P
authors.lastname: Zickler
authors.forename: Earl
authors.initials: E
authors.lastname: Rubin
authors.forename: Joanne
authors.initials: J
authors.lastname: Embree
authors.forename: Prakash
authors.initials: P
authors.lastname: Bhuyan
authors.forename: Andrew
authors.initials: A
authors.lastname: Lee
authors.forename: Minran
authors.initials: M
authors.lastname: Li
authors.forename: Antigona
authors.initials: A
authors.lastname: Tomovici
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage* / Q000009:adverse effects* / Q000276:immunology; D004306:Dose-Response Relationship, Immunologic; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects* / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects* / Q000276:immunology; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D006801:Humans; D007223:Infant; D008297:Male; D022242:Pneumococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects* / Q000276:immunology; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage* / Q000009:adverse effects* / Q000276:immunology; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D022242:Pneumococcal Vaccines; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined; C541235:diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine