DTaP-IPV Booster Dose Protocols Pharmacists Should Know

The Advisory Committee on Immunization Practice has released guidelines for the use of a new combined diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine as a booster dose.

The Advisory Committee on Immunization Practice (ACIP) has released guidelines for the use of a new combined diphtheria and tetanus toxoids and acellular pertussis adsorbed (DTaP) and inactivated poliovirus (IPV) vaccine (DTaP-IPV) as a booster dose.

Approved by the FDA in March 2015, Sanofi Pasteur’s Quadracel provides active immunization against diphtheria, tetanus, pertussis, and polio in children aged 4 to 6 years. The DTaP-IPV combination vaccine’s approval was based on the results of a phase 3 study demonstrating that it has similar safety, immunogenicity, and reactogenicity profiles as DTaP and IPV vaccines administered separately with or without a co-administered second dose of measles, mumps, and rubella and varicella vaccines.

Quadracel joins GlaxoSmithKline’s Kinrix as the second DTaP-IPV combination vaccine, both of which are included in the federal Vaccines for Children Program.

In a Morbidity and Mortality Weekly Report from the US Centers for Disease Control and Prevention, ACIP endorsed the licensed indications for Quadracel and provided guidelines for its use as a booster dose.

Quadracel is indicated as the fifth dose in the DTaP series and the fourth or fifth dose in the IPV series in children who have received 4 doses of the Sanofi Pasteur’s DTaP-IPV-Hib (Pentacel) and/or DTaP (Daptacel) vaccine. It is administered as an intramuscular injection, preferably into the deltoid muscle of the upper arm.

Because data on the safety and immunogenicity of interchanging DTaP vaccines from different manufacturers are limited, ACIP recommends that the same manufacturer's DTaP vaccines should be used for each dose in the series whenever feasible. However, health care professionals should not defer vaccination just because the type of previously administered DTaP vaccine is unavailable or unknown.

Children aged 7 years or older or 4 years or younger should not receive Quadracel, but if it is inadvertently administered before age 4 for an earlier dose of the DTaP and/or IPV series, and if minimum interval requirements have been met, then the dose may be counted for the DTaP and/or IPV series and does not need to be repeated, ACIP said.

Because the final dose in the IPV series must be administered at or after age 4—regardless of the number of previous doses, and with a minimum interval of 6 months from the previous dose—a Quadracel dose administered before age 4 is not a valid final dose of the IPV series, ACIP concluded.