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Vaccine Detail
Infanrix |
Vaccine Information |
- Vaccine Name: Infanrix
- Target Pathogen: Corynebacterium diphtheriae
- Target Disease: Diphtheria
- 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: 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: 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. 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).
- Preparation: The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract.
- Immunization Route: Intramuscular injection (i.m.)
- 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). Because of the substantial risks of complications from pertussis disease in infants, completion of the primary series of 3 doses of vaccine early in life is strongly recommended. INFANRIX should not be administered to any infant before the age of 6 weeks, or to individuals 7 years of age or older. When passive protection against tetanus or diphtheria is required, Tetanus Immune Globulin or Diphtheria Antitoxin, respectively, should be administered at separate sites (FDA: INFANRIX).
- Contraindication: Hypersensitivity to any component of the vaccine and ti should not be administered to anyone with a known previous allergic reaction associated with the vaccine (FDA: INFANRIX).
- Description: 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. 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).
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Host Response |
Human Response
- Vaccination Protocol: Efficacy of diphtheria toxoid used in INFANRIX was determined on the basis of immunogenicity studies (FDA: INFANRIX).
- Side Effects: Side effects of vaccination include: injection site reactions, fever, irritability, drowsiness, loss of appetite, and vomiting (FDA: INFANRIX).
- Efficacy: A VERO cell toxin neutralizing test confirmed the ability of infant sera, obtained 1 month after a 3-dose primary series, to neutralize diphtheria toxin. Levels of diphtheria antitoxin were achieved in 100% of the sera tested (FDA: INFANRIX).
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References |
FDA: INFANRIX: FDA: INFANRIX [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm101568.htm]
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