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Vaccine Detail

TENIVAC
Vaccine Information
  • Vaccine Name: TENIVAC
  • Target Pathogen: Corynebacterium diphtheriae
  • Target Disease: Diphtheria
  • Product Name: Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
  • Tradename: TENIVAC
  • Manufacturer: Sanofi Pasteur, Ltd
  • Vaccine Ontology ID: VO_0000102
  • Type: Toxoid vaccine
  • Status: Licensed
  • Location Licensed: USA (License #1726)
  • Host Species for Licensed Use: Human
  • Adjuvant:
    • Adjuvant name:
    • VO adjuvant ID: VO_0000128
    • Description: Is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older (Tenivac).
  • Preparation: Corynebacterium diphtheriae is grown in modified Mueller’s 223 growth medium. After purification by ammonium sulfate fractionation, diphtheria toxin is 224 detoxified with formaldehyde and diafiltered.(Tenivac)
  • Immunization Route: Intramuscular injection (i.m.)
  • Storage: TENIVAC vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE.
  • Approved Age for Licensed Use: TENIVAC is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older (Tenivac).
  • Contraindication: Severe allergic reaction (e.g., anaphylaxis) to a previous dose of TENIVAC, or any other tetanus or diphtheria toxoid-containing vaccine, or any component of this vaccine is a contraindication.(Tenivac)
  • Description: Is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older.(Tenivac)
Host Response

Human Response

  • Vaccination Protocol: A clinical study evaluated 17 participants ages 6 to 56 years conducted in Canada (Tenivac).
  • Immune Response: Four weeks following the second dose, all 17 participants had a serum diphtheria antitoxin level ≥0.01 IU/mL. Four weeks following the third dose, all 17 participants had a serum diphtheria antitoxin level >0.1 IU/mL (Tenivac).
  • Side Effects: The most frequent solicited injection site reaction within 0-3 days following TENIVAC was pain, reported in 78.3% of study participants 11-59 years of age and 35.3% of participants ≥60 years of age. Contraindicatons include pain, redness, swelling, and systemic adverse effects (Tenivac).
References
FDA: TENIVAC: FDA: TENIVAC vaccine information [https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM152826.pdf]