Indications and Usage ( |
01/2023 |
Dosage and Administration ( |
01/2023 |
Adverse Reactions |
|||||
---|---|---|---|---|---|
Adolescents 11-17 years Adacel N (%) |
Adolescents 11-17 years Td N |
Adults 18-64 years Adacel N (%) |
Adults 18-64 years Td N (%) |
||
|
77.8 |
71.0 | 65.7 | 62.9 | |
|
18.0 | 15.6 | 15.1 | 10.2 | |
|
1.5 | 0.6 | 1.1 | 0.9 | |
|
20.9 | 18.3 | 21.0 | 17.3 | |
|
6.5 | 5.7 | 7.6 | 5.4 | |
|
6.4 | 5.5 | 5.8 | 5.5 | |
|
2.8 | 3.6 | 3.2 | 2.7 | |
|
20.8 | 19.7 | 24.7 | 21.6 | |
|
5.9 | 4.6 | 8.0 | 8.4 | |
|
6.0 | 5.3 | 6.2 | 4.8 | |
|
2.7 | 2.9 | 4.0 | 3.0 | |
|
5.0 |
2.7 | 1.4 | 1.1 | |
(≥102.0°F to ≤103.0°F) |
0.9 | 0.6 | 0.4 | 0.2 | |
|
0.2 | 0.1 | 0.0 | 0.2 |
Adverse Reaction | |||||
---|---|---|---|---|---|
Adolescents 11-17 years Adacel N (%) |
Adolescents 11-17 years Td N (%) |
Adults 18-64 years Adacel N (%) |
Adults 18-64 years Td N (%) |
||
|
43.7 | 40.4 | 33.9 | 34.1 | |
|
14.2 | 11.1 | 11.4 | 10.5 | |
|
2.0 | 1.5 | 2.8 | 2.1 | |
|
30.4 | 29.9 | 21.9 | 18.8 | |
|
8.5 | 6.9 | 6.1 | 5.7 | |
|
1.3 | 0.9 | 1.2 | 0.9 | |
|
30.2 | 27.3 | 24.3 | 20.7 | |
|
9.8 | 7.5 | 6.9 | 6.1 | |
|
1.2 | 1.0 | 1.3 | 0.5 | |
|
15.1 | 12.6 | 8.1 | 6.6 | |
|
3.2 | 2.5 | 1.3 | 1.6 | |
|
0.5 | 0.1 | 0.7 | 0.5 | |
|
11.3 | 11.7 | 9.1 | 7.0 | |
|
2.6 | 2.5 | 2.5 | 2.1 | |
|
0.3 | 0.1 | 0.5 | 0.5 | |
|
13.3 | 12.3 | 9.2 | 7.9 | |
|
3.2 | 3.2 | 2.5 | 1.8 | |
|
1.0 | 0.6 | 0.8 | 0.5 | |
|
6.6 | 5.3 | 6.5 | 4.1 | |
|
1.0 | 0.5 | 1.2 | 0.5 | |
|
0.1 | 0.0 | 0.1 | 0.0 | |
|
10.3 | 10.2 | 10.3 | 11.3 | |
|
1.9 | 2.0 | 2.2 | 2.7 | |
|
0.3 | 0.0 | 0.5 | 0.5 | |
|
4.6 | 2.8 | 3.0 | 1.8 | |
|
1.2 | 1.1 | 1.0 | 0.9 | |
|
0.5 | 0.3 | 0.5 | 0.2 | |
|
2.7 | 2.0 | 2.0 | 2.3 |
Adverse Reaction | Adacel (N=999) (%) |
Td Adsorbed (N=328) (%) |
|
---|---|---|---|
N = number of participants with available data | |||
|
87.1 | 87.4 | |
|
28.5 | 31.4 | |
|
3.6 | 2.8 | |
|
6.4 | 5.5 | |
|
2.1 | 2.8 | |
|
0.2 | 0.0 | |
|
6.9 | 8.0 | |
|
2.4 | 2.2 | |
|
0.3 | 0.0 | |
|
0.9 | 1.8 | |
|
0.3 | 0.6 | |
|
0.2 | 0.3 | |
|
41.4 | 39.1 | |
|
12.4 | 10.5 | |
|
2.6 | 4.0 | |
|
33.3 | 30.8 | |
|
9.3 | 9.8 | |
|
3.0 | 3.7 | |
|
58.1 | 58.2 | |
|
18.7 | 16.9 | |
|
3.0 | 3.1 |
Anti-Tetanus toxoid (IU/mL) Pre-vaccination |
Anti-Tetanus toxoid (IU/mL) Pre-vaccination |
Anti-Tetanus toxoid (IU/mL) 1 Month Post-vaccination |
Anti-Tetanus toxoid (IU/mL) 1 Month Post-vaccination |
Anti-Tetanus toxoid (IU/mL) 1 Month Post-vaccination |
|||
---|---|---|---|---|---|---|---|
Age Group (years) |
Vaccine | N |
% ≥0.10 (95% CI) |
% ≥1.0 (95% CI) |
% ≥0.10 (95% CI) |
% ≥1.0 (95% CI) |
% Booster (95% CI) |
|
|
|
99.6 (98.6, 100.0) |
44.6 (40.3, 49.0) |
100.0 (99.3, 100.0) |
99.6 (98.6, 100.0) |
91.7 (89.0, 93.9) |
|
|
|
99.2 (98.0, 99.8) |
43.8 (39.5, 48.2) |
100.0 (99.3, 100.0) |
99.4 (98.3, 99.9) |
91.3 (88.5, 93.6) |
|
|
|
97.3 (95.9, 98.3) |
72.9 (69.6, 76.1) |
100.0 (99.5, 100.0) |
97.8 (96.5, 98.8) |
63.1 (59.5, 66.6) |
|
|
|
95.9 (93.8, 97.4) |
70.3 (66.2, 74.3) |
99.8 (98.9, 100.0) |
98.2 (96.7, 99.2) |
66.8 (62.5, 70.9) |
Anti-Diphtheria toxin (IU/mL) Pre-vaccination |
Anti-Diphtheria toxin (IU/mL) Pre-vaccination |
Anti-Diphtheria toxin (IU/mL) 1 Month Post-vaccination |
Anti-Diphtheria toxin (IU/mL) 1 Month Post-vaccination |
Anti-Diphtheria toxin (IU/mL) 1 Month Post-vaccination |
|||
---|---|---|---|---|---|---|---|
Age Group (years) |
Vaccine | N |
% ≥0.10 (95% CI) |
% ≥1.0 (95% CI) |
% ≥0.10 (95% CI) |
% ≥1.0 (95% CI) |
% Booster (95% CI) |
|
|
|
72.5 (68.5, 76.3) |
15.7 (12.7, 19.1) |
99.8 (98.9, 100.0) |
98.7 (97.3, 99.5) |
95.1 (92.9, 96.8) |
|
|
|
70.7 (66.5, 74.6) |
17.3 (14.1, 20.8) |
99.8 (98.9, 100.0) |
98.4 (97.0, 99.3) |
95.0 (92.7, 96.7) |
|
|
|
62.6 (59.0, 66.1) |
14.3 (11.9, 17.0) |
94.1 (92.1, 95.7) |
78.0 (74.8, 80.9) |
87.4 (84.8, 89.7) |
|
|
|
63.3 (59.0, 67.5) |
16.0 (12.9, 19.5) |
95.1 (92.8, 96.8) |
79.9 (76.1, 83.3) |
83.4 (79.9, 86.5) |
Adolescents 11-17 Years of Age Adacel GMC Ratio (95% CIs) |
Adults 18-64 Years of Age Adacel GMC Ratio (95% CIs) |
|
---|---|---|
|
3.6 (2.8, 4.5) |
2.1 (1.6, 2.7) |
|
5.4 (4.5, 6.5) |
4.8 (3.9, 5.9) |
|
3.2 (2.5, 4.1) |
3.2 (2.3, 4.4) |
|
5.3 (3.9, 7.1) |
2.5 (1.8, 3.5) |
Adolescents 11-17 Years of Age N |
Adolescents 11-17 Years of Age % (95% CI) |
Adults 18-64 Years of Age N |
Adults 18-64 Years of Age % (95% CI) |
Predefined Acceptable Rates % |
|
---|---|---|---|---|---|
|
524 | 92.0 (89.3, 94.2) |
739 | 84.4 (81.6, 87.0) |
81.2 |
|
526 | 85.6 (82.3, 88.4) |
739 | 82.7 (79.8, 85.3) |
77.6 |
|
525 | 94.5 (92.2, 96.3) |
739 | 93.8 (91.8, 95.4) |
86.4 |
|
526 | 94.9 (92.6, 96.6) |
739 | 85.9 (83.2, 88.4) |
82.4 |
Vaccine | N |
Pre-vaccination ≥0.1 IU/mL (95% CI) |
Pre-vaccination ≥1.0 IU/mL (95% CI) |
1 month post-vaccination ≥0.1 IU/mL (95% CI) |
1 month post-vaccination ≥1.0 IU/mL (95% CI) |
1 month post-vaccination %Booster (95% CI) |
|
---|---|---|---|---|---|---|---|
Anti- Tetanus Toxoid (ELISA - IU/mL) | Adacel | 944-948 | 97.2 (96.0; 98.2) |
62.3 (59.1; 65.4) |
100.0 (99.6; 100.0) |
99.9 (99.4; 100.0) |
74.5 (71.6; 77.2) |
Anti- Tetanus Toxoid (ELISA - IU/mL) | Td |
315-317 | 96.5 (93.8; 98.2) |
63.8 (58.2; 69.1) |
100.0 (98.8; 100.0) |
100.0 (98.8; 100.0) |
81.6 (76.9; 85.7) |
Anti- Diphtheria Toxin (ELISA - IU/mL) | Adacel | 945-948 | 84.7 (82.2; 86.9) |
29.1 (26.2; 32.1) |
99.8 (99.2; 100.0) |
94.9 (93.3; 96.2) |
83.2 (80.6; 85.5) |
Anti- Diphtheria Toxin (ELISA - IU/mL) | Td |
315-317 | 83.8 (79.3; 87.7) |
29.8 (24.8; 35.2) |
99.4 (97.7; 99.9) |
94.0 (90.8; 96.4) |
84.1 (79.6; 88.0) |
Antigen | N | Adacel GMC (EU/mL) |
Adacel (95% CI) |
N | DAPTACEL GMC (EU/mL) |
DAPTACEL (95% CI) |
Adacel/DAPTACEL GMC Ratio |
(95% CI) |
---|---|---|---|---|---|---|---|---|
|
935 | 102 | (94.9; 110) | 366 | 98.1 | (90.9; 106) | 1.04 | (0.92; 1.18) |
|
948 | 209 | (200; 217) | 80 | 39.9 | (34.6; 46.1) | 5.22 | (4.51; 6.05) |
|
948 | 318 | (302; 334) | 80 | 108 | (91.4; 128) | 2.94 | (2.46; 3.51) |
|
948 | 745 | (711; 781) | 80 | 341 | (270; 431) | 2.18 | (1.84; 2.60) |
Adacel (N=948) |
Adacel (N=948) |
Pre-specified criteria for Booster Response Rates |
Adacel minus Pre-specified Booster Response Rates |
Adacel minus Pre-specified Booster Response Rates |
|
---|---|---|---|---|---|
Antigen | n/M | % (95% CI) | % | Difference (%) | (95% CI) |
N = number of subjects analyzed according to Per-Protocol Analysis Set M = number of subjects with available data for the considered endpoint n = number of subjects fulfilling the item listed in the first column |
|||||
|
693/894 | 77.5 (74.6; 80.2) | 61.4 | 16.12 | (13.27; 18.73) |
|
651/945 | 68.9 (65.8; 71.8) | 73.1 | -4.21 | (-7.23; -1.34) |
|
617/945 | 65.3 (62.2; 68.3) | 83.9 | -18.61 | (-21.7; -15.6) |
|
537/945 | 56.8 (53.6; 60.0) | 75.9 | -19.07 | (-22.3; -16.0) |