Table 2.
Safety profile of whole‐virion H5N1 vaccine in adults
| 1·25 μg (Phase I) | 2·5 μg (Phase I) | 5 μg (Phases I + II) | 10 μg (Phases I + II) | 15 μg (Phases Ib + II) | Sum | |
|---|---|---|---|---|---|---|
| n | 24 | 24 | 124 | 226 | 110 | 508 |
| Total | 66·7 (16) | 45·8 (11) | 32·3 40) | 31·9 (72) | 45·5 (50) | 37·2 (189) |
| Mild | 58·3 (14) | 33·3 (8) | 25·8 (32) | 19·9 (45) | 31·8 (35) | 26·4 (134) |
| Moderate | 8·3 (2) | 12·5 (3) | 6·5 (8) | 9·3 (21) | 11·8 (13) | 9·3 (47) |
| Severe | 0·0 (0) | 0·0 (0) | 0·0 (0) | 2·7 (6) | 1·8 (2) | 1·6 (8) |
| Local | 66·7 (16) | 33·3 (8) | 23·4 (29) | 22·6 (51) | 30·0 (33) | 27·0 (137) |
| Systemic | 25·0 (6) | 41·7 (10) | 20·2 (25) | 24·3 (55) | 30·9 (34) | 25·6 (130) |
| First vaccination | 62·5 (15/24) | 45·8 (11/24) | 28·2 (35/124) | 29·2 (66/226) | 40·0 (44/110) | 33·7 (171/508) |
| Second vaccination | 29·2 (7/24) | 20·8 (5/24) | 10·8 (13/120) | 7·2 (16/221) | 18·1 (19/105) | 12·1 (60/494) |
Data are incidences of adverse reactions (number of participants reporting adverse reactions/number of participants receiving vaccine).