Dose:   0.5 ml/dose IM

Frequency: DTaP-HepB-IPV is aproved for the primary series of immunizations at 2, 4, and 6 months of age. The vaccine should not be administered to any infant < 6 weeks of age or any person > 7 years of age. The recommended interval is 6-8 weeks, preferably 8 weeks. An information sheet about the vaccine that explain the risks and benefits (produced by the CDC) can be found on the Vaccine Information Statements web site www.immunize.org/vis.

Comments: Pediarix combines DTaP (diphtheria and tetanus toxoids and acellular pertussis), HepB (recombinant hepatitis B vaccine), and IPV (inactivated poliovirus vaccine). Though this is a new vaccine, it does not contain any new antigens. The vaccine combination is given in a 0.5 ml dose IM at 2 months, 4 months, and 6 months of age during the first year of life. Available data indicate that prematurely born infants should be immunized at the usual chronological age using the standard doses (immunizations in special circumstances). The immunologic responses following 3 doses of DTaP-HepB-IPV were generally similar to those following 3 doses of separately administered Infanrix (DTaP-IPV) and Engerix-B (Hep B). Immunogenicity data from simultaneous administration of DTaP-HepB-IPV with Haemophilus influenzae type b (Hib) conjugate vaccine and pneumococcal conjugate vaccine (PCV) are unavailable. Except for fever, the rates of most solicited local and systemic adverse events following DTaP-HepB-IPV were comparable to rates observed following separately administered vaccines (Clin Pediatr 2003; 42:393-400).

Children who have a true contraindication to pertussis immunization (i.e. encephalopathy not caused by another identifiable cause within 7 days after DTaP immunizations or an anaphylactic reaction after DTaP immunizations) should receive no further vaccines containing pertussis antigen (contraindication to pertussis). 

Toxicity: Localized pain, erythema, and induration have been noted within 48 hours of immunization. The incidences of both local and systemic side effects due to DTaP-HepB-IPV were reported to be similar to those seen following separate vaccine administration except for fever. In an ongoing study, infants who received the first dose of DTaP-HepB-IPV with Hib vaccine and PCV had higher rates of fever compared with infants who received separately administered vaccines (MMWR 2003; 52:203-4).  A nodule may be palpable at the site of injection for several weeks, rarely sterile abscesses have been reported. Mild systemic occur quite frequently. Rash, allergic reactions, and respiratory difficulties (including apnea) have also been observed. More serious systemic reactions such as fever of 40.5^o C or higher, persistent, inconsolable crying, or hypotensive/hyporesponsive episode occur infrequently. 

Preparation: DTaP-HepB-IPV (Pediarix) vaccine is available in a single dose vial. Store at 2^o to 8^o C (35^o to 46^o F). Do not freeze. Vaccine contains an antibacterial preservative. SHAKE VIAL WELL before withdrawing dose.