TABLE 3.
Adverse events after W0
| Parameter | Placebo (n = 35) | Vaccine (n = 63) | Total (n = 98) |
|---|---|---|---|
| No. (%) of participants presenting | |||
| At least one AE | 35 (100) | 59 (94) | 94 (96) |
| At least one biological AE | 5 (14) | 9 (14) | 14 (14) |
| At least one clinical AE | 35 (100) | 59 (94) | 94 (96) |
| AE by maximal grade, n (%) | 220 | 405 | 625 |
| Grade 1: mild | 84 (38) | 217 (54) | 301 (48) |
| Grade 2: moderate | 123 (56) | 170 (42) | 293 (47) |
| Grade 3: severe | 12 (5) | 18 (4) | 30 (5) |
| Grade 4: life threatening | 1 (0) | 0 | 1 (0) |
| SAE among all AEs, n (%) | |||
| No | 213 (97) | 397 (98) | 610 (98) |
| Yes | 7 (3) | 8 (2) | 15 (2) |
| Median duration of AE (in days) (Q1; Q3) | 24 (5; 90) | 12 (3; 49) | 15 (3; 62) |
| Participants presenting at least one AE related to vaccine, n (%) | 12 (34) | 34 (54) | 46 (47) |
| AE related to vaccine by maximal grade, n (%) | 36 | 105 | 141 |
| Grade 1: mild | 19 (53) | 85 (81) | 104 (74) |
| Grade 2: moderate | 17 (47) | 19 (18) | 36 (26) |
| Grade 3: severe | 0 | 1 (1) | 1 (1) |
| Grade 4: life threatening | 0 | 0 | 0 |
| SAE among AE related to vaccine, n (%) | |||
| No | 36 (100) | 104 (99) | 140 (99) |
| Yes | 0 | 1 (1) | 1 (1) |