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

Disclosures

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

In This Article

Indications and Guidance for use

DTaP-IPV-Hib-HepB is licensed for use in children aged 6 weeks through 4 years (before the fifth birthday) (Table).[1] DTaP-IPV-Hib-HepB is only indicated for use in infants at ages 2, 4, and 6 months.

For the prevention of diphtheria, tetanus and pertussis, children are recommended to receive a 3-dose primary series of DTaP, at ages 2, 4, and 6 months, and booster doses at ages 15–18 months and 4–6 years.[12] DTaP-IPV-Hib-HepB can be used for the first 3 doses of the recommended DTaP series but should not be used for the fourth or fifth dose. However, if DTaP-IPV-Hib-HepB is inadvertently given for either booster dose, the dose does not need to be repeated with another DTaP-containing vaccine when the proper spacing of previous doses is maintained. Circumstances might warrant an accelerated schedule to provide early protection against pertussis, starting as soon as the infant is aged 6 weeks, with the second and third DTaP doses administered no earlier than 4 weeks after each preceding dose. The recommended minimum age for the third dose of the DTaP-IPV-Hib-HepB vaccine is 24 weeks, the minimum age for completion of the HepB vaccine series. Therefore, this combination vaccine is not recommended for use for the third dose of the primary series on an accelerated schedule at 4-week intervals for the prevention of pertussis.

For prevention of poliomyelitis, children are recommended to receive 4 doses of IPV, at ages 2, 4, 6–18 months, and 4–6 years.[13] DTaP-IPV-Hib-HepB may be used for the first 3 doses of the IPV series but is not indicated for the fourth dose; however, if DTaP-IPV-Hib-HepB is inadvertently given for the booster dose, the dose does not need to be repeated with another IPV-containing vaccine, when the proper spacing of previous doses is maintained.

For prevention of invasive H. influenzae type b disease, children are recommended to receive a primary series (2 or 3 doses, depending on the vaccine used) of a Hib conjugate vaccine and a booster dose of vaccine at age 12–15 months.[14] Although monovalent PRP-OMP Hib vaccines are licensed as a 2-dose primary series at ages 2 and 4 months, DTaP-IPV-Hib-HepB is licensed as a 3-dose primary series. Therefore, 3 doses of a Hib conjugate-containing vaccine are needed to complete the primary series if DTaP-IPV-Hib-HepB is used for any doses. DTaP-IPV-Hib-HepB should not be used for the booster dose (after completion of the 3-dose primary series). Any Hib conjugate vaccine licensed for a booster dose can be used. If DTaP-IPV-Hib-HepB is inadvertently given for the booster dose, the dose does not need to be repeated with another Hib-containing vaccine, when the proper spacing of previous doses is maintained.

For prevention of hepatitis B, children are recommended to receive 3 doses of a HepB vaccine at ages 0, 1–2, and 6–18 months, with variations depending on the maternal hepatitis B infection status, infant birthweight, and vaccine manufacturer.[15] Universal HepB vaccination of all infants beginning at birth provides a critical safeguard and prevents infection among infants born to hepatitis B surface antigen (HBsAg)–positive mothers not identified prenatally. DTaP-IPV-Hib-HepB is not licensed for the birth dose but can be used for doses given at age ≥6 weeks to infants of HBsAg-negative mothers. In addition to this FDA-approved use, 3 doses of DTaP-IPV-Hib-HepB can be administered to an infant aged ≥6 weeks born to a woman who is HBsAg-positive or whose HBsAg status is unknown. For adequate immune response, the last dose of HepB vaccine should be given at age ≥24 weeks; therefore, the third dose of DTaP-IPV-Hib-HepB is not recommended to be given before age 24 weeks. If it is given earlier, an additional dose of HepB vaccine should be given at age ≥24 weeks, maintaining proper spacing with previous doses.

Data are limited on the safety and immunogenicity of interchanging vaccines from different manufacturers for the vaccination series in a child. Whenever feasible, the same manufacturer's product should be used to complete the primary series; however, vaccination should not be deferred if the specific vaccine product previously administered is unavailable or unknown.[4]

DTaP-IPV-Hib-HepB can be used for children aged <5 years requiring a catch-up schedule. However, vaccine doses should not be administered at intervals less than the minimum intervals provided in Table 3–1 of the General Best Practices Guidelines.[4]

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