Table 2.
Incidence of solicited adverse events within 7 days after each vaccination (safety population)
| Severity | 1 st dose, n*(%) | 2 nd dose, n*(%) | 3 rd dose, n*(%) | ||||
|---|---|---|---|---|---|---|---|
| KD-287 (n = 102) | JEV-GCC (n = 102) | KD-287 (n = 102) | JEV-GCC (n = 100) | KD-287 (n = 100) | JEV-GCC (n = 96) | ||
| Erythema | Mild | 9 (8.8) | 18 (17.6) | 7 (6.9) | 14 (14.0) | 7 (7.0) | 14 (14.6) |
| Moderate | 3 (2.9) | 2 (2.0) | 5 (4.9) | 2 (2.0) | 7 (7.0) | 6 (6.3) | |
| Severe | 1 (1.0) | 0 (0) | 0 (0) | 0 (0) | 1 (1.0) | 0 (0) | |
| Pain | Mild | 14 (13.7) | 10 (9.8) | 3 (2.9) | 5 (5.0) | 18 (18.0) | 11 (11.5) |
| Moderate | 2 (2.0) | 2 (2.0) | 2 (2.0) | 1 (1.0) | 2 (2.0) | 3 (3.1) | |
| Severe | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (1.0) | |
| Swelling | Mild | 3 (2.9) | 7 (6.9) | 6 (5.9) | 7 (7.0) | 5 (5.0) | 11 (11.5) |
| Moderate | 2 (2.0) | 1 (1.0) | 2 (2.0) | 1 (1.0) | 1 (1.0) | 2 (2.1) | |
| Severe | 1 (1.0) | 0 (0) | 0 (0) | 0 (0) | 1 (1.0) | 0 (0) | |
| Fever | Mild | 19 (18.6) | 10 (9.8) | 13 (12.7) | 12 (12.0) | 13 (13.0) | 14 (14.6) |
| Moderate | 8 (7.8) | 4 (3.9) | 2 (2.0) | 4 (4.0) | 1 (1.0) | 3 (3.1) | |
| Severe | 4 (3.9) | 1 (1.0) | 2 (2.0) | 3 (3.0) | 0 (0) | 1 (1.0) | |
| Crying | Mild | 27 (26.5) | 20 (19.6) | 15 (14.7) | 6 (6.0) | 14 (14.0) | 14 (14.6) |
| Moderate | 5 (4.9) | 4 (3.9) | 3 (2.9) | 6 (6.0) | 2 (2.0) | 3 (3.1) | |
| Severe | 2 (2.0) | 0 (0) | 0 (0) | 1 (1.0) | 0 (0) | 1 (1.0) | |
| Irritability | Mild | 12 (11.8) | 11 (10.8) | 5 (4.9) | 6 (6.0) | 13 (13.0) | 4 (4.2) |
| Moderate | 1 (1.0) | 4 (3.9) | 2 (2.0) | 5 (5.0) | 0 (0) | 6 (6.3) | |
| Severe | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | |
| Vomiting | Mild | 8 (7.8) | 11 (10.8) | 4 (3.9) | 3 (3.0) | 1 (1.0) | 4 (4.2) |
| Moderate | 2 (2.0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | |
| Severe | 1 (1.0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | |
| Diarrhea | Mild | 17 (16.7) | 11 (10.8) | 3 (2.9) | 5 (5.0) | 3 (3.0) | 4 (4.2) |
| Moderate | 4 (3.9) | 1 (1.0) | 0 (0) | 2 (2.0) | 0 (0) | 2 (2.1) | |
| Severe | 0 (0) | 1 (1.0) | 0 (0) | 0 (0) | 1 (1.0) | 1 (1.0) | |
| Decreased appetite | Mild | 10 (9.8) | 13 (12.7) | 5 (4.9) | 8 (8.0) | 6 (6.0) | 8 (8.3) |
| Moderate | 2 (2.0) | 0 (0) | 0 (0) | 1 (1.0) | 1 (1.0) | 0 (0) | |
| Severe | 2 (2.0) | 0 (0) | 1 (1.0) | 0 (0) | 0 (0) | 1 (1.0) | |
| Somnolence | Mild | 9 (8.8) | 12 (11.8) | 8 (7.8) | 7 (7.0) | 14 (14.0) | 17 (17.7) |
| Moderate | 0 (0) | 1 (1.0) | 0 (0) | 1 (1.0) | 0 (0) | 0 (0) | |
| Severe | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | |
*Number of subjects reporting the specific characteristic.