TY - JOUR T1 - Immunogenicity and reactogenicity of Infanrix™ when co-administered with meningococcal MenACWY-TT conjugate vaccine in toddlers primed with MenHibrix™ and Pediarix™. AU - Leonardi,Michael, AU - Latiolais,Thomas, AU - Sarpong,Kwabena, AU - Simon,Michael, AU - Twiggs,Jerry, AU - Lei,Paul, AU - Rinderknecht,Stephen, AU - Blatter,Mark, AU - Bianco,Veronique, AU - Baine,Yaela, AU - Friedland,Leonard R, AU - Baccarini,Carmen, AU - Miller,Jacqueline M, Y1 - 2014/10/08/ PY - 2014/06/06/received PY - 2014/08/21/revised PY - 2014/09/16/accepted PY - 2014/10/12/entrez PY - 2014/10/12/pubmed PY - 2015/10/20/medline KW - Co-administration KW - DTaP vaccine KW - HibMenCY-TT KW - MenACWY-TT KW - Quadrivalent meningococcal vaccine SP - 924 EP - 32 JF - Vaccine JO - Vaccine VL - 33 IS - 7 N2 - BACKGROUND: Co-administration of an investigational quadrivalent meningococcal serogroups A, C, W and Y tetanus toxoid conjugate vaccine (MenACWY-TT) with the fourth dose of diphtheria-tetanus-acellular pertussis vaccine (DTaP) at age 15-18 months was investigated in 3-dose Haemophilus influenzae type b-meningococcal serogroups C/Y conjugate vaccine (HibMenCY-TT)-primed toddlers. METHODS: Infants were randomized (5:1) and primed at 2, 4 and 6 months of age with HibMenCY-TT and DTaP-hepatitis B-inactivated poliovirus (DTaP-HBV-IPV) vaccine, or Hib-TT and DTaP-HBV-IPV (Control). HibMenCY-TT+ DTaP-HBV-IPV vaccinees were re-randomized (2:2:1) to receive MenACWY-TT at 12-15 months and DTaP at 15-18 months (MenACWY-TT group); MenACWY-TT co-administered with DTaP at 15-18 months (Coad group); or HibMenCY-TT at 12-15 months and DTaP at 15-18 months (HibMenCY-TT group). Controls received DTaP at 15-18 months. Only children in the HibMenCY-TT group received a fourth dose of Hib conjugate vaccine due to Hib conjugate vaccine shortage at the time of the study. DTaP immunogenicity and reactogenicity were assessed one month post-vaccination. RESULTS: Pre-defined statistical non-inferiority criteria between Coad and Control groups were met for diphtheria, tetanus and filamentous haemagglutinin but not pertussis toxoid and pertactin. Following vaccination ≥99% of children had anti-diphtheria/anti-tetanus concentrations ≥1.0 IU/ml. Pertussis GMCs were lower in all investigational groups versus Control. In post hoc analyses, pertussis antibody concentrations were above those in infants following 3-dose DTaP primary vaccination in whom efficacy against pertussis was demonstrated (Schmitt, von König, et al., 1996; Schmitt, Schuind, et al., 1996). The reactogenicity profile of the Coad group was similar to DTaP administered alone. CONCLUSION: Routine booster DTaP was immunogenic with an acceptable safety profile when co-administered with MenACWY-TT vaccine in HibMenCY-TT-primed toddlers. These data support the administration of a fourth DTaP dose following a 4-dose HibMenCY-TT vaccination series, or co-administered with MenACWY-TT in HibMenCY-TT-primed children. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/25305567/Immunogenicity_and_reactogenicity_of_Infanrix™_when_co_administered_with_meningococcal_MenACWY_TT_conjugate_vaccine_in_toddlers_primed_with_MenHibrix™_and_Pediarix™_ DB - PRIME DP - Unbound Medicine ER -