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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)
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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).
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References |
FDA: TENIVAC: FDA: TENIVAC vaccine information [https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM152826.pdf]
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