Table 4.
Summary of safety data from Day 0 to Day 30 post-vaccination with MenACYW-TT or MPSV4 (safety analysis set).
| MenACYW-TT (N = 199) % (95% CI) |
MPSV4 (N = 100) % (95% CI) |
|
|---|---|---|
| Immediate | ||
| Unsolicited systemic AE | 0 (0.0, 1.8) | 0 (0.0, 3.6) |
| Unsolicted AR | 0 (0.0, 1.8) | 0 (0.0, 3.6) |
| Solicited reaction | 57.8 (50.6, 64.7) | 53.0 (42.8, 63.1) |
| Solicited injection site reaction | 35.7 (29.0, 42.8) | 35.0 (25.7, 45.2) |
| Erythema | 11.6 (7.5, 16.8) | 5.0 (1.6, 11.3) |
| Swelling | 7.6 (4.3, 12.2) | 2.0 (0.2, 7.0) |
| Pain | 30.7 (24.3, 37.6) | 32.0 (23.0, 42.1) |
| Solicited systemic reaction | 46.7 (39.6, 53.9) | 41.0 (31.3, 51.3) |
| Fever | 1.5 (0.3, 4.4) | 1.0 (0.0, 5.5) |
| Headache | 23.6 (17.9, 30.1) | 28.0 (19.5, 37.9) |
| Malaise | 22.1 (16.5, 28.5) | 15.0 (8.6, 23.5) |
| Myalgia | 35.2 (28.6, 42.2) | 26.0 (17.7, 35.7) |
| Unsolicited AE | 20.6 (15.2, 26.9) | 17.0 (10.2, 25.8) |
| Unsolicited non-serious systemic AE | 17.1 (12.1, 23.0) | 17.0 (10.2, 25.8) |
| Unsolicited AR | 6.5 (3.5, 10.9) | 2.0 (0.2, 7.0) |
| SAE | 0.0 (0.0, 1.8) | 0.0 (0.0, 3.6) |
| Death | 0.0 (0.0, 1.8) | 0.0 (0.0, 3.8) |
AE, adverse event; AR, adverse reaction; SAE, serious adverse event.