• Vaccine Name: Pediarix
• Target Pathogen: Corynebacterium diphtheriae
• Target Disease: Diphtheria
• 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: 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: It 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: yeast, neomycin,polymyxin B
• Preparation: The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract. The diphtheria, tetanus, and pertussis antigens are individually adsorbed onto aluminum hydroxide then diluted and combined to produce the final formulated vaccine (FDA: Pediarix).
• Immunization Route: Intramuscular injection (i.m.)
• Storage: The vaccine should be 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, the vaccine should also not be administered to anyone with a previous allergic reaction to a dose of the vaccine (FDA: Pediarix).
• Description: It 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

• Vaccination Protocol: A double-blind, randomized, active Diphtheria and Tetanus Toxoids (DT)-controlled trial conducted in Italy, sponsored by the National Institutes of Health (NIH), assessed the absolute protective efficacy of INFANRIX when administered at 2, 4, and 6 months of age (FDA: Pediarix).
• Immune Response: In response to vaccination, all patients seem to have around 90-100% antibody response.
• Side Effects: The most reported side effects included: injection site reactions, fever, drowsiness, loss of appetite and fussiness (FDA: Pediarix).