FDA licensed Pentacel in 2008 as a 4-dose series in infants and children at ages 2, 4, 6, and 15–18 months. It should not be used for any dose in the primary series for children age 5 years or older or as the booster dose for children ages 4 through 6 years. The DTaP-IPV component is supplied as a sterile liquid, which is used to reconstitute lyophilized (freeze-dried) ActHIB vaccine. The two components of the vaccine should be stored together in the carton to reduce the chance of giving one component of the vaccine without the other. The DTaP-IPV component should never be administered alone.
Ask the Experts: Combination Vaccines: DTaP-IPV/Hib (Pentacel, Sanofi)
Yes, as long as minimum intervals between doses are maintained.
Use of DTaP-IPV solution as the diluent for the Hib component is specifically written both on the Pentacel box AND on the DTaP-IPV vial label. The DTaP-IPV component will count as valid doses of DTaP and IPV vaccines, but take measures to prevent this error in the future. You cannot mix the Hib component with sterile water. ActHib must ONLY be reconstituted with either the DTaP-IPV solution supplied with Pentacel, or with a specific ActHib saline diluent. If you have a vial of lyophilized ActHib but neither diluent, you must contact the manufacturer (Sanofi) and obtain ActHib diluent.
While administration of Pentacel to a 5-year-old would be considered off-label and a vaccine administration error, the doses of DTaP and IPV can be counted as valid and do not need to be repeated. Hib vaccine is not routinely administered after a child has reached the age of 5 years so it is also a vaccine administration error. You should explain this error to the parents and assure them that the extra Hib dose will cause no harm.
Yes. CDC recommends that whenever feasible, only one manufacturer’s DTaP product be used for the entire pertussis series, but that vaccinations should not be deferred if the DTaP product previously given is unavailable or unknown.
Yes. In 2009 ACIP updated its recommendations for use of IPV, partly in response to the availability of newer combination vaccines (e.g., Pentacel) that include an IPV component. The change did not apply to children who had already completed an acceptable 4-dose series of IPV before the updated schedule was published in August 2009. Since August 2009, ACIP has recommended that children receive at least 1 dose of IPV at age 4 through 6 years, even if they have previously received 4 doses. The interval between the next-to-last and last dose should be at least 6 months. This updated recommendation applies to all IPV-containing vaccines, including combination vaccines as well as IPV given as a single product. This means that some children may receive a total of 5 doses, a practice ACIP considers acceptable. This is similar to the recommendation for the last dose in the DTaP series. To view the current polio vaccine recommendations, go to the ACIP recommendations website at www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/polio.html.
Pentacel (DTaP-IPV/Hib) inadvertently administered to children six years of age and older is considered a vaccine administration error. However, none of the vaccine components need to be repeated.