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PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis (whooping cough), all known subtypes of hepatitis B virus, and poliomyelitis caused by poliovirus Types 1, 2, and 3 as a three-dose primary series in infants born of HBsAg-negative mothers, beginning as early as 6 weeks of age.

Important Safety Information

• In clinical studies, adverse events in infants receiving PEDIARIX included injection-site reactions (pain, redness, or swelling), fever, and fussiness
• PEDIARIX is contraindicated in infants with known hypersensitivity to any component of the vaccine including yeast, neomycin, and polymyxin B. Encephalopathy within 7 days of administration of a previous pertussis-containing vaccine or a progressive neurologic disorder is a contraindication
• Administration of PEDIARIX was associated with higher rates of fever relative to separately administered vaccines
• The decision to give PEDIARIX should be based on potential benefits and risks if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, or if adverse events have occurred in temporal relation to receipt of a pertussis-containing vaccine
• Vaccination with PEDIARIX may not protect 100% of susceptible individuals

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*PEDIARIX is for infants born to mothers without evidence of hepatitis B infection. It is typically given at two, four, and six months of age. PEDIARIX can also be used in children younger than seven years of age who need “catch-up” vaccinations.