Abstract
ABSTRACT Combined hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTaP-HBV-IPV/Hib) can further reduce the number of injections in pediatric immunization schedules of countries currently using pentavalent DTaP combination vaccines. This open-label, randomized, multicenter study (NCT02096263) conducted in the United States evaluated the immunogenicity and safety of DTaP-HBV-IPV/Hib vaccine compared with concomitant administration of DTaP-HBV-IPV and HibA or DTaP-IPV/Hib and HBV vaccines. We randomized (1:1:1) infants to receive 3-dose priming with DTaP-HBV-IPV/Hib boosted with DTaP+ HibB, DTaP-HBV-IPV+ HibA boosted with DTaP+ HibA, or DTaP-IPV/Hib+ HBV boosted with DTaP-IPV/Hib, at 2, 4, 6, and 15–18 months of age. We enrolled and vaccinated 585 participants, 486 received a booster, and 476 completed the study. Of these, 466 participants were included in the primary and 408 in the booster according-to-protocol cohorts for immunogenicity. We demonstrated non-inferiority of DTaP-HBV-IPV/Hib vaccine to DTaP-HBV-IPV+ HibA co-administered vaccines in terms of geometric mean concentrations for pertussis antibodies post-primary vaccination. Post-primary vaccination, seroprotection/seropositivity rates for all vaccine antigens were similarly high between DTaP-HBV-IPV/Hib (≥ 94.8%), DTaP-HBV-IPV+ HibA (≥ 98.1%) or DTaP-IPV/Hib+ HBV (≥ 97.8%) groups. We observed robust immune responses post-booster, indicating effective priming by the 3 regimens. Reactogenicity was similar in the 3 groups. Twenty-eight serious adverse events were reported during the study; 3 were considered related to vaccination and resolved by the end of the study. These results confirm that DTaP-HBV-IPV/Hib could be a valuable additional source of pediatric DTaP, IPV, HBV, and Hib-containing vaccine in countries that currently use multivalent vaccines.
Highlights
The introduction of new vaccines in already complex pediatric vaccination schedules can be challenging
Our current study further found that immune responses to the other antigens were similar in children receiving DTaP-HBV-IPV/Haemophilus influenzae type b (Hib) to those receiving separate DTaP-HBV-IPV and HibA vaccines, both after primary vaccination and after the DTaP and Hib booster doses
Consistent with previous studies, our results suggest that administering Hib together with DTaPHBV-IPV in the same injection did not interfere with the immune response to these additional antigens.[11,20,28,29]
Summary
The introduction of new vaccines in already complex pediatric vaccination schedules can be challenging. Combination vaccines help reduce the number of injections needed during childhood vaccination and may decrease discomfort for children, increase acceptance by parents and pediatricians, reduce costs, and improve vaccination coverage and compliance.[1,2] In the United States (US), the 2 pentavalent combination vaccines, which have been available for more than 10 years, are diphtheria, tetanus, and acellular pertussis (DTaP), hepatitis B (HBV) and inactivated poliovirus vaccine (DTaP-HBV-IPV, Pediarix, GSK);[3] and DTaP, IPV and Haemophilus influenzae type b vaccine (DTaP-IPV/Hib, Pentacel, Sanofi Pasteur).[4] In the US, these combination vaccines are typically administered concomitantly with recommended monovalent HBV and Hib vaccines, both of which have well-established immunogenicity and safety profiles.[5,6,7,8]. The study assessed the safety and immunogenicity of the other antigens following the 3 primary doses in infancy and a booster dose in the second year of life, in US children
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