Adacel

STN: BL 125111
Proper Name: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
Tradename: ADACEL
Manufacturer: Sanofi Vaccines Canada Ltd

Indication

Adacel is a vaccine indicated for:

• Immunization for prevention of tetanus, diphtheria and pertussis as a single dose in persons 11 through 64 years of age 
• Immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age.

Product Information

Product Information

• Package Insert - Adacel
• Patient Prescribing Information (PPI) Sheet - Adacel

Supporting Documents

• July 30, 2026 Approval Letter - ADACEL
• May 11, 2023 Approval Letter - Adacel
• BLA Clinical Review Memorandum (125111/904) - ADACEL
• January 9, 2023 Statistical Review - ADACEL
• January 9, 2023 Approval Letter - Adacel
• December 28, 2020 Approval Letter - Adacel
• January 11, 2019 Summary Basis for Regulatory Action - Adacel
• January 11, 2019 Approval Letter - Adacel
  To include re-administration in adolescents and adults following a previous dose.
• September 29, 2017 Approval Letter - Adacel
• Supporting Documents older than three years - Adacel

Related Information

• FDA Approves a New Combination Vaccine to Help Protect Both Adolescents and Adults against Whooping Cough - ARCHIVED