Table 3.
Adverse events by vaccination group.
| Preferred term | Placebo (N = 12) n (%) | BCG (N = 24) n (%) | H4:IC31 (N = 24) n (%) | H56:IC31 (N = 24) n (%) |
|---|---|---|---|---|
| Participants with at least 1 AE | 6 (50) | 23 (96) | 17 (71) | 15 (63) |
| Participants with at least 1 solicited AE | 6 (50) | 21 (88) | 17 (71) | 15 (63) |
| Participants with at least 1 unsolicited AE | 2 (17) | 15 (62) | 2 (8) | 1 (4) |
| Fatigue | 1 (8) | 7 (29) | 6 (25) | 7 (29) |
| Headache | 2 (17) | 7 (29) | 6 (25) | 6 (25) |
| Chills | 2 (177) | 2 (8) | 5 (21) | 6 (25) |
| Myalgia | 1 (8) | 4 (17) | 2 (8) | 5 (21) |
| Nausea | 1 (8) | 2 (8) | 3 (13) | 5 (21) |
| Arthralgia | 1 (8) | 3 (13) | 1 (4) | 3 (13) |
| Diarrhea | 1 (8) | 5 (21) | 1 (4) | 1 (4) |
| Tachycardia | 1 (8) | 0 | 0 | 0 |
| Vomiting | 0 | 1 (4) | 0 | 0 |
| Pyrexia | 1 (8) | 0 | 1 (4) | 2 (8) |
| Abdominal pain | 0 | 2 (8) | 0 | 0 |
| Feeling cold | 0 | 1 (4) | 1 (4) | 0 |
| Injection site scar | 0 | 2 (8) | 0 | 0 |
| Injection site pain | 3 (25) | 14 (58) | 14 (58) | 13 (54) |
| Injection site abscess | 0 | 1 (4) | 0 | 0 |
| Injection site discoloration | 0 | 1 (4) | 0 | 0 |
| Injection site exfoliation | 0 | 1 (4) | 0 | 0 |
| Injection site rash | 0 | 1 (4) | 0 | 0 |
| Injection site scab | 0 | 1 (4) | 0 | 0 |