• Vaccine Name: DAPTACEL
• Target Pathogen: Corynebacterium diphtheriae
• Target Disease: Diphtheria
• 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
• Adjuvant:
  • Adjuvant name:
  • VO adjuvant ID: VO_0000127
  • 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.
• Preparation: DAPTACEL vaccine is a sterile isotonic suspension of pertussis antigens and diphtheria toxoids adsorbed on aluminum phosphate. Corynebacterium diphtheriae is grown in modified Mueller’s growth medium. After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered (FDA: DAPTACEL).
• Storage: DAPTACEL vaccine 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

• Vaccination Protocol: In a randomized, double-blinded pertussis vaccine efficacy trial, the Sweden I Efficacy Trial, conducted in Sweden during 1992-1995, the safety of DAPTACEL vaccine was compared with DT and a whole-cell pertussis DTP vaccine. A standard diary card was kept for 14 days after each dose and follow-up telephone calls were made 1 and 14 days after each injection. Telephone calls were made monthly to monitor the occurrence of severe events and/or hospitalizations for the 2 months after the last injection (FDA: DAPTACEL).
• 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: Side effects of vaccination are: injection site reactions, irritability, fussiness, and lethargy.