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 one 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 haemagglutinin, pertactin, and fimbriae types 2 and 3, and rates of seroprotection against (Hib) polyribosylribitol phosphate capsular polysaccharide (PRP), hepatitis B surface antigen (HBsAg), 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 PRP, HBsAg, 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 one 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).