• Vaccine Name: Infanrix
• Target Pathogen: Clostridium tetani
• Target Disease: Tetanus
• Product Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
• Tradename: Infanrix
• Manufacturer: GlaxoSmithKline Biologicals
• Vaccine Ontology ID: VO_0000064
• CDC CVX code: 20
• Type: Toxoid vaccine
• Status: Licensed
• Location Licensed: USA (License #1617 ), Canada
• Host Species for Licensed Use: Human
• Antigen: Diphtheria and tetanus toxoids and 3 pertussis antigens [inactivated pertussis toxin (PT), filamentous hemagglutinin (FHA), and pertactin (69 kiloDalton outer membrane protein)] (FDA Infanrix).
• Adjuvant: aluminum hydroxide vaccine adjuvant
  • Adjuvant name: aluminum hydroxide vaccine adjuvant
  • VO adjuvant ID: VO_0000127
  • Description: The vaccine is an noninfectious, sterile combination of diphtheria and tetanus toxoids and 3 pertussis antigens [inactivated pertussis toxin (PT), filamentous hemagglutinin (FHA), and pertactin (69 kiloDalton outer membrane protein)] adsorbed onto aluminum hydroxide (FDA Infanrix).
• Preparation: Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. The toxin is detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration (FDA Infanrix).
• Storage: Store INFANRIX refrigerated between 2° and 8°C (36° and 46°F). Do not freeze.
• Approved Age for Licensed Use: INFANRIX is indicated for active immunization against diphtheria, tetanus, and pertussis (whooping cough) as a 5-dose series in infants and children 6 weeks to 7 years of age (prior to seventh birthday). INFANRIX should not be administered to any infant before the age of 6 weeks, or to individuals 7 years of age or older (FDA Infanrix).
• Contraindication: Hypersensitivity to any component of the vaccine is a contraindication, the vaccine should not be administered to anyone with encephalopathy, progressive neurological disorders, or an allergic reaction to a previous dose (FDA Infanrix).
• Description: The vaccine is an noninfectious, sterile combination of diphtheria and tetanus toxoids and 3 pertussis antigens [inactivated pertussis toxin (PT), filamentous hemagglutinin (FHA), and pertactin (69 kiloDalton outer membrane protein)] adsorbed onto aluminum hydroxide (FDA Infanrix).

Human Response

• Immune Response: Ninety percent of infants who received Hib simultaneously with INFANRIX achieved anti-PRP antibodies >1 mcg/mL (N = 72), and 96% to 100% of infants who received OPV simultaneously with INFANRIX showed protective neutralizing antibody to poliovirus Types 1, 2, and 3 (N = 60-61) (FDA Infanrix).
• Side Effects: Injection site reactions, irritability, drowsiness, loss of appetite, vomiting, and crying (FDA Infanrix).