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Vaccine Detail

Boostrix
Vaccine Information
  • Vaccine Name: Boostrix
  • Target Pathogen: Corynebacterium diphtheriae
  • Target Disease: Diphtheria
  • Product Name: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
  • Tradename: Boostrix
  • Manufacturer: GlaxoSmithKline Biologicals
  • Vaccine Ontology ID: VO_0000015
  • CDC CVX code: 20, 115
  • Type: Toxoid vaccine
  • Status: Licensed
  • Location Licensed: USA (License #1617)
  • Host Species for Licensed Use: Human
  • Adjuvant:
    • Adjuvant name:
    • VO adjuvant ID: VO_0000128
    • Description: BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) is a noninfectious, sterile, vaccine for intramuscular administration. It contains tetanus toxoid, diphtheria toxoid, and pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin). The antigens are the same as those in INFANRIX, but BOOSTRIX is formulated with reduced quantities of these antigens (Boostrix).
  • Preparation: Shake vigorously to obtain a homogeneous, turbid, white suspension before administration. Do not use if resuspension does not occur with vigorous shaking.
    The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract. The bovine materials used in this extract are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor are at risk of bovine spongiform encephalopathy (BSE). The diphtheria toxin is detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration .
  • Immunization Route: Intramuscular injection (i.m.)
  • Storage: Store refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze.
  • Approved Age for Licensed Use: BOOSTRIX is a vaccine indicated for active booster immunization against tetanus, diphtheria, and pertussis as a single dose. BOOSTRIX is approved for use in individuals 10 through 64 years of age (Boostrix).
  • Contraindication: A severe allergic reaction after a previous dose of any tetanus toxoid-diphtheria toxoid or pertussis antigen containing vaccine or any component of this vaccine is a contraindication to administration of BOOSTRIX (Boostrix).
  • Description: BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) is a noninfectious, sterile, vaccine for intramuscular administration. It contains tetanus toxoid, diphtheria toxoid, and pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin). The antigens are the same as those in INFANRIX, but BOOSTRIX is formulated with reduced quantities of these antigens (Boostrix).
Host Response

Human Response

  • Vaccination Protocol: In a randomized, observer-blinded, controlled study in the US, 3,080 adolescents 10 to 18 years of age received a single dose of BOOSTRIX and 1,034 received the control Td vaccine (Boostrix).
  • Immune Response: Prior to vaccination, antibody levels in subjects were 85.8% while after vaccination were 99.9% (Boostrix).
  • Side Effects: Common solicited adverse events (≥15%) in adolescents were pain, redness, and swelling at the injection site, increase in arm circumference of injected arm, headache, fatigue, and gastrointestinal symptoms.(Boostrix)
References
Boostrix: Boostrix [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm172925.htm]