DTaP-IPV-Hib-HepB vaccine has safety profile consistent with licensed comparator vaccines
FRIDAY, Feb. 7, 2020 (HealthDay News) — The hexavalent combined diphtheria and tetanus toxoids and acellular pertussis (DTaP) adsorbed, inactivated poliovirus (IPV), Haemophilus influenza type b (Hib) conjugate (meningococcal protein conjugate), and hepatitis B (HepB; recombinant) vaccine (DTaP-IPV-Hib-HepB) has been included in the federal Vaccines for Children program, according to research published in the Feb. 7 issue of the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.
Sara E. Oliver, M.D., from the CDC in Atlanta, and Kelly L. Moore, M.D., from the Vanderbilt School of Medicine in Nashville, Tennessee, reviewed evidence relating to potential benefits and harms of DTaP-IPV-Hib-HepB.
The researchers reviewed six phase III studies that examined the safety and immunogenicity of DTaP-IPV-Hib-HepB, including two noninferiority studies. After the third dose of DTaP-IPV-Hib-HepB, immunological responses were assessed. The measured antibodies were noninferior to licensed comparator vaccines with the exception that noninferiority was not met for the geometric mean concentration against one of five pertussis antigens at one month after completion of the three-dose infant series; noninferiority criteria were met for all pertussis antigens at a second measured endpoint. The safety profile of DTaP-IPV-Hib-HepB was consistent with that of the licensed component vaccines. DTaP-IPV-Hib-HepB is licensed for use in children aged 6 weeks through 4 years and is indicated for use in the primary vaccination series in infants at ages 2, 4, and 6 months.
“DTaP-IPV-Hib-HepB can be used for children aged <5 years requiring a catch-up schedule. However, the vaccine doses should not be administered at intervals less than the minimum intervals provided in Table 3-1 of the General Best Practices Guidelines," the authors write.
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