Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular 破伤风类毒素,减低白喉类毒素与无细胞-医学精

3 ug
Al3+
0.33 mg 0.33 mg
Td 2 Lf 5 Lf
0.33 mg
Basis for Licensure:
Demonstration of non-inferiority of the safety profile of ADACEL™ as compared to a U.S.-licensed Td vaccine.
Basis for Licensure (cont):
Demonstration of the consistency of manufacture based on safety and immunogenicity of three consecutively produced ADACEL™ vaccine lots.
Questions:
Are the available data adequate to support the efficacy of ADACEL™ in individuals 11-64 years of age? VOTE
Are the available data adequate to support the safety of ADACEL™ when administered to individuals 11 – 64 years of age? VOTE
Basis for Licensure (cont):
Demonstration of non-inferiority of the immune responses of tetanus and diphtheria, as compared to a U.S.-licensed Td vaccine: – Percentage of subjects attaining seroprotective levels – Booster responses
Discussion:
Please identify any issues which should be
addressed, including post-licensure studies.
APL Manufactured Vaccine Formulations:
Antigen ADACEL™ DAPTACEL®
ຫໍສະໝຸດ Baidu
Diphtheria 2 Lf
15 Lf
Tetanus 5 Lf
5 Lf
PT
2.5 ug
10 ug
FHA
5 ug
5 ug
FIM 2/3 2.5 ug
2.5 ug
PRN
3 ug
Basis for Licensure (cont):
Demonstration of boosting responses to each of the pertussis antigens.
Demonstration of non-inferiority of the immune responses to the pertussis antigens as compared to the immune responses observed in the Sweden I Efficacy Trial.
Manufacturer: Aventis Pasteur Limited (APL), Toronto, Ontario
Application received August 13, 2019
Proposed Indication/Dosage:
Active immunization for the prevention of diphtheria, tetanus and pertussis in adolescents and adults aged 11-64 years as a single 0.5 mL intramuscular booster dose
ADACEL™
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine,
Adsorbed (Tdap)
March 15,2019 FDA Introduction, Martha Monser
Regulatory History