• Vaccine Name: DAPTACEL
• Target Pathogen: Clostridium tetani
• Target Disease: Tetanus
• Product Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
• Tradename: DAPTACEL
• Manufacturer: Sanofi Pasteur, Ltd.
• Vaccine Ontology ID: VO_0000029
• CDC CVX code: 20, 106
• Type: Toxoid vaccine
• Status: Licensed
• Location Licensed: USA (License #1726)
• Host Species for Licensed Use: Human
• Antigen: Isotonic suspension of pertussis antigens and diphtheria and tetanus toxoids (FDA: DAPTACEL).
• Adjuvant:
  • Adjuvant name:
  • VO adjuvant ID: VO_0000128
• 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: DAPTACEL).
• Storage: should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE.
• Approved Age for Licensed Use: DAPTACEL is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five dose series in infants and children 6 weeks through 6 years of age (prior to 7th birthday) (FDA: DAPTACEL).
• Contraindication: Severe allergic reaction (e.g. anaphylaxis) after a previous dose of any diphtheria toxoid, tetanus toxoid, or pertussis-containing vaccine, or any component of DAPTACEL, encephalopathy within 7 days of a previous pertussis-containing vaccine with no other identifiable cause and, progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized. (FDA: DAPTACEL).
• Description: DAPTACEL is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five-dose series in infants and children 6 weeks through 6 years of age.

Human Response

• Immune Response: One clinical study found that among a random subset of children who received the fourth dose of DAPTACEL vaccine at 15-16 months of age, 96.5% achieved diphtheria antitoxin levels of ≥1.0 IU/mL after the fourth dose. (FDA: DAPTACEL).
• Side Effects: The most common side effects reported are: injection site reactions, fussiness/irritability, inconsolable crying, and decreased activity/lethargy, and fever (FDA: DAPTACEL).
• Efficacy: A tetanus antitoxin level ≥0.1 IU/mL as measured by the ELISA used in clinical studies of DAPTACEL vaccine is considered protective (FDA: DAPTACEL).