Halperin Scott A, Tapiéro Bruce, Dionne Marc, Meekison William, Diaz-Mitoma Francisco, Zickler Paul, Rubin Earl, Embree Joanne, Bhuyan Prakash, Lee Andrew, Li Minran, Tomovici Antigona
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.
Pediatr Infect Dis J. 2014 Jan;33(1):73-80. doi: 10.1097/01.inf.0000437806.76221.20.
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).
Hum Vaccin Immunother. 2021-1-2
Pharmacoepidemiol Drug Saf. 2018-4
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