Table 2.
Comparison of the Presence of Reactogenicity Events by Treatment Group
| Number (Percent) of Subjects by Treatment | ||||||
|---|---|---|---|---|---|---|
| Placebo | 200 µg Schedule 1 |
200 µg Schedule 2 |
400 µg Schedule 1 |
400 µg Schedule 2 |
p-value | |
| (N=100) | (N=50) | (N=50) | (N=50) | (N=51) | ||
| Local | ||||||
| Ache | 96 (96.0) | 48 (96.0) | 43 (86.0) | 47 (94.0) | 49 (96.1) | 0.129 |
| Burning | 42 (42.0) | 23 (46.0) | 22 (44.0) | 21 (42.0) | 23 (45.1) | 0.988 |
| Erythema | 39 (39.0) | 29 (58.0) | 23 (46.0) | 27 (54.0) | 22 (43.1) | 0.180 |
| Heat | 42 (42.0) | 23 (46.0) | 25 (50.0) | 27 (54.0) | 22 (43.1) | 0.661 |
| Swelling/Induration | 60 (60.0) | 33 (66.0) | 32 (64.0) | 33 (66.0) | 29 (56.9) | 0.827 |
| Tenderness | 95 (95.0) | 49 (98.0) | 44 (88.0) | 48 (96.0) | 50 (98.0) | 0.126 |
| Systemic | ||||||
| Fever | 10 (10.0) | 5 (10.0) | 2 (4.0) | 8 (16.0) | 6 (11.8) | 0.403 |
| General Discomfort/Malaise | 79 (79.0) | 38 (76.0) | 38 (76.0) | 42 (84.0) | 42 (82.4) | 0.803 |
| Headache | 67 (67.0) | 35 (70.0) | 32 (64.0) | 35 (70.0) | 36 (70.6) | 0.945 |
| Myalgia | 86 (86.0) | 39 (78.0) | 41 (82.0) | 46 (92.0) | 45 (88.2) | 0.315 |
| Nausea | 44 (44.0) | 17 (34.0) | 25 (50.0) | 21 (42.0) | 25 (49.0) | 0.501 |
| Vomiting | 6 (6.0) | 3 (6.0) | 2 (4.0) | 2 (4.0) | 8 (15.7) | 0.111 |