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Vaccine Detail

TENIVAC
Vaccine Information
  • Vaccine Name: TENIVAC
  • Target Pathogen: Clostridium tetani
  • Target Disease: Tetanus
  • 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: TENIVAC is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older (FDA: Tenivac).
  • Preparation: Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. (FDA: 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 (FDA: 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.(FDA: Tenivac)
  • Description: Is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older(FDA: Tenivac)
Host Response

Human Response

  • Immune Response: Among adults 65 years of age and over who received TENIVAC vaccine (N = 419), 94.5% (95% 273 confidence interval 91.9, 96.5) had a post-vaccination diphtheria antitoxoid level 275 ≥0.1 IU/mL (FDA: 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(FDA: Tenivac)
References
FDA: Tenivac: FDA: Tenivac [https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM152826.pdf]