• Vaccine Name: Pediarix
• Target Pathogen: Clostridium tetani
• Target Disease: Tetanus
• Product Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined
• Tradename: Pediarix
• Manufacturer: GlaxoSmithKline Biologicals
• Vaccine Ontology ID: VO_0000082
• CDC CVX code: 110
• Type: Subunit vaccine + Inactivated or "killed" vaccine
• Status: Licensed
• Location Licensed: USA (License #1617)
• Host Species for Licensed Use: Human
• Adjuvant:
  • Adjuvant name:
  • VO adjuvant ID: VO_0000127
  • Description: The vaccine contains diphtheria and tetanus toxoids, 3 pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin [69 kiloDalton outer membrane protein]), hepatitis B surface antigen, plus poliovirus Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett) (FDA: Pediarix).
• Allergen: Polymyxin B Neomycin, Latex in plunger stopper of prefilled syringe
• Preparation: Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. The toxin is then detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration (FDA: Pediarix).
• Immunization Route: Intramuscular injection (i.m.)
• Storage: Store PEDIARIX refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze.
• Approved Age for Licensed Use: 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. PEDIARIX should not be administered to any infant before the age of 6 weeks, or to individuals 7 years of age or older (FDA: Pediarix).
• Contraindication: Hypersensitivity to any component of the vaccine, including yeast, neomycin, and polymyxin B, is a contraindication. The vaccine should not be administered to anyone with a previous alergic reaction following a dose of the vaccine, or if they have encephalopathy or a progressive neurologic disorder (FDA: Pediarix).
• Description: The vaccine contains diphtheria and tetanus toxoids, 3 pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin [69 kiloDalton outer membrane protein]), hepatitis B surface antigen, plus poliovirus Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett) (FDA: Pediarix).

Human Response

• Immune Response: In response to vaccination, all patients seem to have around 90-100% antibody response.
• Side Effects: Most common side effects reported are: local injection site reactions, fever, fussiness/irritability, and loss of appetite.
• Efficacy: Following immunization, protection persists for at least 10 years.