Table 5 Incidence of solicited adverse reactions as defined by the EMA in the first three days after vaccination
Intradermal vaccine | Adjuvanted vaccine | |
|---|---|---|
(N = 398) | (N = 397) | |
n | n | |
(%; [95% CI]) | (%; [95% CI]) | |
≥ 1 adverse reaction | 51 | 55 |
(12.8 [9.7;16.5]) | (13.9 [10.6;17.6]) | |
Injection-site indurationa | 0 | 0 |
(0 [0.0;0.9]) | (0 [0.0;0.9]) | |
Injection-site ecchymosis | 13 | 12 |
(3.3 [1.8;5.5]) | (3.0 [1.6;5.2]) | |
Pyrexiab | 6 | 12 |
(1.5 [0.6;3.3]) | (3.0 [1.6;5.2]) | |
Malaise | 19 | 20 |
(4.8 [2.9;7.4]) | (5.0 [3.1;7.7]) | |
Shivering | 24 | 23 |
(6.0 [3.9;8.8]) | (5.8 [3.7;8.6]) |