Pediarix contains the vaccine components DTaP, IPV, and HepB. The primary series is 3 doses (0.5 mL) given intramuscularly at 2, 4, and 6 months of age. Pediarix is licensed by the Food and Drug Administration (FDA) for only the first 3 doses of the DTaP series. It should not be given to infants younger than 6 weeks of age or to children 7 years or older.
Ask the Experts: Combination Vaccines: DTaP-IPV-HepB (Pediarix, GSK)
Yes, although the package inserts states that Pediarix should only be given to infants born to mothers who are HBsAg-negative, ACIP voted in 2003 to expand its recommendations for use to include infants born to women whose HBsAg status is positive or unknown beginning no earlier than age 6 weeks.
Yes. As with any combination vaccine, it may be used when any of the components are indicated and none are contraindicated. Providers must observe spacing intervals such that the minimum interval between doses is equal to the greatest interval of any of the individual antigens. Pediarix may only be used in children younger than age 7 years.
No. Pediarix is licensed for doses 1, 2, and 3 of the DTaP primary series through age 6 years.
No. Pediarix is intended to be used only for doses 1, 2, or 3 of the DTaP primary series; consequently, using Pediarix for DTaP #4 is off-label and not recommended. You should take measures to prevent this error in the future. The DTaP, IPV, and HepB doses given in this scenario do not need to be repeated as long as you met the recommended minimum intervals for each vaccine component (DTaP, IPV, HepB). If you did meet the minimum intervals, the doses should be counted as valid.