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Adacel
Clinical Pharmacology
Adacel
† Seroprotection rates at ≥ 0.10 IU/mL and booster response rates to ADACEL vaccine were non-inferior to Td vaccine (upper limit of the 95% CI on the difference for Td vaccine minus ADACEL vaccine <10%).
† Seroprotection rates at ≥1.0 IU/mL were not designed as a primary endpoint, however ADACEL vaccine met non-inferiority criteria (upper limit of the 95% CI on the difference for Td vaccine minus ADACEL vaccine <10%) at this level.
Table 3: Ratio of Pertussis Antibody Geometric Mean Concentrations (GMCs)† Observed One Month After a Dose of ADACEL Vaccine in Adolescents and Adults Compared with Those Observed in Infants One Month Following Three Doses at 2, 4 and 6 Months of Age in an Efficacy Trial with DAPTACEL Vaccine
| Adolescents ADACEL/DAPTACEL GMC Ratio* (95% CIs) | Adults ADACEL/DAPTACEL GMC Ratio* (95% CIs) | |
| Anti-PT | 3.6 (2.8, 4.5)† | 2.1 (1.6, 2.7)† |
| Anti-FHA | 5.4 (4.5, 6.5)† | 4.8 (3.9, 5.9)† |
| Anti-PRN | 3.2 (2.5, 4.1)† | 3.2 (2.3, 4.4)† |
| Anti-FIM | 5.3 (3.9, 7.1)† | 2.5 (1.8, 3.5)† |
† GMC following ADACEL vaccine was non-inferior to GMC following DAPTACEL vaccine (lower limit of 95% CI on the ratio of GMC for ADACEL vaccine divided by DAPTACEL vaccine >0.67).
† Antibody GMCs, measured in arbitrary ELISA units were calculated separately for infants, adolescents and adults.
| | Adolescents N = 524 % (95% CI) | Adults N = 739 % (95% CI) | Pre-defined Acceptable Rates* %† |
| Anti-PT | 92 (89.3, 94.2) | 84.4 (81.6, 87.0) | 81.2 |
| Anti-FHA | 85.6 (82.3, 88.4) | 82.7 (79.8, 85.3) | 77.6 |
| Anti-PRN | 94.5 (92.2, 96.3) | 93.8 (91.8, 95.4) | 86.4 |
| Anti-FIM | 94.9 (92.6, 96.6) | 85.9 (83.2, 88.4) | 82.4 |
Generic Name: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
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