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Vaccine Detail

Adacel
Vaccine Information
  • Vaccine Name: Adacel
  • Target Pathogen: Corynebacterium diphtheriae
  • Target Disease: Diphtheria
  • Product Name: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
  • Tradename: Adacel
  • Manufacturer: Sanofi Pasteur, Ltd (USA: License #1726)
  • Vaccine Ontology ID: VO_0000005
  • CDC CVX code: 20, 115
  • Type: Toxoid vaccine
  • Status: Licensed
  • Location Licensed: USA: License #1726
  • Host Species for Licensed Use: Human
  • Antigen: Pertussis
  • Adjuvant:
    • Adjuvant name:
    • VO adjuvant ID: VO_0000128
    • Description: It is a sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components adsorbed onto aluminum phosphate, for intramuscular administration.
  • Preparation: Corynebacterium diphtheriae is grown in modified Mueller‘s growth medium. After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered. Diphtheria toxoid is adsorbed onto aluminum phosphate (Adacel).
  • Immunization Route: Intramuscular injection (i.m.)
  • Storage: Adacel vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE
  • Approved Age for Licensed Use: Adacel vaccine is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis as a single dose in persons 11 through 64 years of age.
  • Contraindication: A severe allergic reaction (e.g., anaphylaxis) after a previous dose of Adacel vaccine or any other tetanus toxoid, diphtheria toxoid or pertussis containing vaccine or any other component of this vaccine is a contraindication to vaccination with Adacel vaccine (Adacel).
  • Description: It is a sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components adsorbed onto aluminum phosphate, for intramuscular administration.
Host Response

Human Response

  • Vaccination Protocol: The principal immunogenicity study was a comparative, multi-center, randomized, observer blind, controlled trial which enrolled 4,480 participants; 2,053 adolescents (11-17 years of age). and 2,427 adults (18-64 years of age). Enrollment was stratified by age to ensure adequate representation across the entire age range. Participants had not received a tetanus or diphtheria toxoid containing vaccine within the previous 5 years (Adacel).
  • Immune Response: Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response. (Adacel)
  • Side Effects: A severe allergic reaction (e.g., anaphylaxis) after a previous dose of Adacel vaccine. Also, headache, body ache or muscle weakness, tiredness, chills, sore and swollen joints, nausea, lymph node swelling, diarrhea, vomiting, and rash may result (Adacel).
References
Adacel: Adacel [http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm172481.htm]