Licensure of a Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus influenzae Type b Conjugate, and Hepatitis B Vaccine, and Guidance for Use in Infants

Sara E. Oliver MD; Kelly L. Moore, MD


Morbidity and Mortality Weekly Report. 2020;69(5):136-139. 

In This Article

Summary of Key Findings

Six Phase III studies evaluated the safety and immunogenicity of DTaP-IPV-Hib-HepB,[5–10] including two noninferiority studies enrolling >4,200 children using the U.S. infant immunization schedule of 2, 4, and 6 months.[5,6] The immunologic responses were assessed after the third dose of DTaP-IPV-Hib-HepB. Overall, the measured antibodies were noninferior to licensed comparator vaccines, with one exception: noninferiority was not met for the geometric mean concentration against one of five pertussis antigens (FHA) 1 month after completion of the 3-dose infant series. However, all pertussis antigens met noninferiority criteria for a second measured endpoint (the percentage that met a prespecified vaccine response). The DTaP-IPV-Hib-HepB vaccine had a safety profile consistent with that of the licensed component vaccines. A higher rate of fever was detected among DTaP-IPV-Hib-HepB recipients when compared with that among pentavalent vaccine (DTaP-IPV/Hib) recipients (47.1%–47.4% versus 33.2%–34.4%).[5,6] However, the rates of fever-related medical events, such as hospital visits or febrile seizures, were similar in the two groups.

Simultaneous administration of DTaP-IPV-Hib-HepB was tested with rotavirus and pneumococcal conjugate vaccines. Concomitant administration did not affect immunogenicity at measured endpoints for rotavirus.[5] One of 13 pneumococcal serotypes, 6B, missed the prespecified noninferiority endpoint after the third dose.[6] Pneumococcal serotype-specific correlates of protection are unknown, and it is unclear whether this would be clinically relevant. However, since the introduction of pneumococcal conjugate vaccines, pneumococcal serotype 6B is rarely detected in nasopharyngeal carriage or as a cause of invasive disease among U.S. children.[11]