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Vaccine Detail

Infanrix
Vaccine Information
  • 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:
    • Adjuvant name:
    • 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).
Host Response

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).
References
FDA Infanrix: FDA Infanrix [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm101568.htm]