• Product Name: Diphtheria and Tetanus Toxoids Adsorbed
• Tradename: None
• Manufacturer: Sanofi Pasteur Inc
• Vaccine Ontology ID: VO_0000033
• CDC CVX code: 28
• Type: Inactivated or "killed" vaccine
• Status: Licensed
• Location Licensed: USA (License #1725), Canada
• Host Species for Licensed Use: Human
• Adjuvant:
  • VO ID: VO_0001240
• Preparation: The vaccine is grown in a peptone-based medium containing bovine extract. The meat used in this medium is US sourced. Both toxins are detoxified with formaldehyde. The detoxified materials are then separately purified by serial ammonium sulfate fractionation and diafiltration.
• Immunization Route: Intramuscular injection (i.m.)
• Storage: Store at 2° to 8°C (35° to 46°F). DO NOT FREEZE.
• Approved Age for Licensed Use: 6 weeks to 6 years of age
• Contraindication: Hypersensitivity to any component of the vaccine, including thimerosal, a mercury derivative, is a contraindication for further use of this vaccine. It is a contraindication to use this or any other related vaccine after an immediate anaphylactic reaction associated with a previous dose (FDA: Diphtheria and Tetanus Toxoids Adsorbed USP).
• Description: The primary series of vaccination for infants 6 weeks through 12 months, consists of 4 doses: administer three 0.5 mL doses intramuscularly 4 to 8 weeks apart. A reinforcing dose is given 6 to 12 months after the third injection (FDA: Diphtheria and Tetanus Toxoids Adsorbed USP).

Human Response

• Vaccination Protocol: A clinical study was performed in 20 children under one year of age to determine the serological responses and the adverse reactions (FDA: Diphtheria and Tetanus Toxoids Adsorbed USP).
• Immune Response: Protective levels of diphtheria antitoxins were detected in 100% of the children following two doses of the vaccine (FDA: Diphtheria and Tetanus Toxoids Adsorbed USP).
• Side Effects: With vaccination, there are little to no adverse reactions to the vaccine. The most widely reported side effects were injection site reactions (FDA: Diphtheria and Tetanus Toxoids Adsorbed USP).
• Efficacy: A complete vaccination series substantially reduces the risk of developing diphtheria, and vaccinated persons who develop disease have milder illness. Protection lasts at least 10 years. Vaccination does not, however, eliminate carriage of C. diphtheriae in the pharynx or nose or on the skin (FDA: Diphtheria and Tetanus Toxoids Adsorbed USP).