Table 5.
Summary of AEs.
| Within 4 weeks after IP dose (all ages) | Vi-DT Group (N = 228) |
Placebo Group (N = 57) |
|||
|---|---|---|---|---|---|
| Number of AEs | Number of Participants (%) | Number of AEs | Number of Participants (%) | ||
| Solicited AE (day 0 to day 7) | 158 | 59 (25.88%) | 32 | 11 (19.30%) | |
| Severity: | Mild | 131 | 54 (23.68%) | 28 | 11 (19.30%) |
| Moderate | 26 | 19 (8.33%) | 3 | 2 (3.51%) | |
| Severe | 1 | 1 (0.44%) | 1 | 1 (1.75%) | |
| Potentially life threatening | 0 | 0 (0.00%) | 0 | 0 (0.00%) | |
| Relatedness: | Definitely Related | 17 | 10 (4.39%) | 0 | 0 (0.00%) |
| Probably Related | 64 | 31 (13.60%) | 11 | 5 (8.77%) | |
| Possibly related | 77 | 29 (12.72%) | 21 | 9 (15.79%) | |
| Unlikely related | 0 | 0 (0.00%) | 0 | 0 (0.00%) | |
| Not Related | 0 | 0 (0.00%) | 0 | 0 (0.00%) | |
| Unsolicited AE | 210 | 137 (60.09%) | 72 | 38 (66.67%) | |
| Severity: | Mild | 201 | 132 (57.89%) | 69 | 38 (66.67%) |
| Moderate | 9 | 8 (3.51%) | 3 | 3 (5.26%) | |
| Severe | 0 | 0 (0.00%) | 0 | 0 (0.00%) | |
| Potentially life threatening | 0 | 0 (0.00%) | 0 | 0 (0.00%) | |
| Relatedness: | Definitely Related | 0 | 0 (0.00%) | 0 | 0 (0.00%) |
| Probably Related | 17 | 15 (6.58%) | 1 | 1 (1.75%) | |
| Possibly related | 38 | 36 (15.79%) | 12 | 10 (17.54%) | |
| Unlikely related | 26 | 23 (10.09%) | 10 | 9 (15.79%) | |
| Not Related | 129 | 94 (41.23%) | 49 | 31 (54.39%) | |
| SAE | 1 | 1 (0.44%) | 0 | 0 (0.00%) | |