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

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2018-06-27 发布于福建
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Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular 破伤风类毒素，减低白喉类毒素与无细胞.ppt

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

ADACEL? Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap) March 15,2005 FDA Introduction, Martha Monser Regulatory History Manufacturer: Aventis Pasteur Limited (APL), Toronto, Ontario Application received August 13, 2004 APL ManufacturedVaccine Formulations: 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 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 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. 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 Discussion: Please identify any issues which should be addressed, including post-licensure studies. * * 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 0.33 mg 0.33 mg 0.33 mg Al3+ - 3 ug 3 ug PRN - 2.5 ug 2.5 ug FIM 2/3 - 5 ug 5 ug FHA - 10 ug 2.5 ug PT 5 Lf 5 Lf 5 Lf Tetanus 2 Lf 15 Lf 2 Lf Diphtheria Td DAPTACEL? ADACEL? Antigen *