TY - JOUR T1 - 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. AU - Halperin,Scott A, AU - Tapiéro,Bruce, AU - Dionne,Marc, AU - Meekison,William, AU - Diaz-Mitoma,Francisco, AU - Zickler,Paul, AU - Rubin,Earl, AU - Embree,Joanne, AU - Bhuyan,Prakash, AU - Lee,Andrew, AU - Li,Minran, AU - Tomovici,Antigona, PY - 2013/12/19/entrez PY - 2013/12/19/pubmed PY - 2014/9/3/medline SP - 73 EP - 80 JF - The Pediatric infectious disease journal JO - Pediatr Infect Dis J VL - 33 IS - 1 N2 - 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). SN - 1532-0987 UR - https://www.unboundmedicine.com/medline/citation/24346596/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_ DB - PRIME DP - Unbound Medicine ER -