Table 2. Solicited injection site and systemic reactions after vaccination: Safety analysis set.
| JE-CV – Booster dose (JE-CV previously vaccinated) n = 345 | JE-CV – First dose (JE-vaccine naïve) n = 46 | Varicella vaccine (Safety control) n = 59 | ||||
|---|---|---|---|---|---|---|
| Children experiencing at least one: | % | (95%CI) | % | (95%CI) | % | (95%CI) |
| Solicited reaction | 37.2 | (32.1, 42.6) | 39.1 | (25.1, 54.6) | 40.7 | (28.1, 54.3) |
| Injection site reaction | 23.5 | (19.2, 28.4) | 30.4 | (17.7, 45.8) | 23.7 | (13.6, 36.6) |
| Injection site pain | 21.2 | (17.0, 25.9) | 28.3 | (16.0, 43.5) | 20.3 | (11.0, 32.8) |
| Injection site erythema | 8.4 | (5.7, 11.9) | 2.2 | (0.1, 11.5) | 6.8 | (1.9, 16.5) |
| Injection site swelling | 5.5 | (3.4, 8.5) | 0 | (0.0, 7.7) | 1.7 | (0.0, 9.1) |
| Systemic reaction | 24.7 | (20.2, 29.6) | 15.2 | (6.3, 28.9) | 28.8 | (17.8, 42.1) |
| Fever | 14.2 | (10.7, 18.4) | 2.2 | (0.1, 11.5) | 15.3 | (7.2, 27.0) |
| Headache | 11.9 | (8.7, 15.8) | 10.9 | (3.6, 23.6) | 13.6 | (6.0, 25.0) |
| Malaise | 14.2 | (10.7, 18.4) | 13.0 | (4.9, 26.3) | 10.2 | (3.8, 20.8) |
| Myalgia | 5.5 | (3.4, 8.5) | 4.3 | (0.5, 14.8) | 3.4 | (0.4, 11.7) |
CI, confidence interval. Solicited injection site reactions were collected daily up to D7; solicited systemic reactions were collected up to D28