STN: BL 125111
Proper Name: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
Manufacturer: Sanofi Pasteur Limited
Adacel is a vaccine indicated for:
- active booster immunization against tetanus, diphtheria and pertussis. Adacel is approved for use in persons 10 through 64 years of age.
- immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age.
- 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 pose.
- September 29, 2017 Approval Letter - Adacel
- Supporting Documents older than three years - Adacel