Table 1.
Treatment-related adverse events reported by two or more participants during the thirty days following first administration, on Day 0 of JE-CV or YF-17D alone, or the co administration of JE-CV and YF-17D, or placebo
| Group and vaccines received at first dose on Day 0 | ||||||
| JE/YF group | YF/JE group | Co-administration | All participants | |||
| System organ class preferred term | (JE-CV + placebo) | (YF-17D + placebo) | JE-CV + YF-17D | Placebo + placebo | ||
| Number of subjects | n = 36 | n = 36 | n = 18 | n = 18 | n = 108 | |
| n (%) | n (%) | n (%) | n (%) | n (%) | ||
| General | 23 (64) | 20 (56) | 7 (39) | 10 (56) | 60 (56) | |
| Fatigue | 16 (44) | 15 (42) | 3 (17) | 10 (56) | 44 (41) | |
| Malaise | 10 (28) | 12 (33) | 2 (11) | 6 (33) | 30 (28) | |
| Pyrexia | 3 (8) | 4 (11) | 0 (-) | 3 (17) | 10 (9) | |
| Chills | 1 (3) | 4 (11) | 1 (6) | 2 (11) | 8 (7) | |
| Injection site | ||||||
| Injection site pain | 10 (28) | 6 (17) | 4 (22) | 2 (11) | 22 (20) | |
| Injection site erythema | 4 (11) | 3 (8) | 1 (6) | 1 (11) | 9 (8) | |
| Injection site swelling | 4 (11) | 0 (-) | 2 (11) | 1 (6) | 7 (7) | |
| Injection site hemorrhage | 1 (3) | 1 (3) | 0 (-) | 0 (-) | 2 (2) | |
| Nervous System | 18 (50) | 20 (56) | 6 (33) | 8 (44) | 52 (48) | |
| Headache | 18 (50) | 20 (56) | 6 (33) | 8 (44) | 52 (48) | |
| Dizziness | 0 (-) | 2 (6) | 0 (-) | 0 (-) | 2 (2) | |
| Musculoskeletal | 7 (19) | 12 (33) | 3 (17) | 5 (28) | 27 (25) | |
| Myalgia | 7 (19) | 12 (33) | 3 (17) | 4 (22) | 26 (24) | |
| Gastrointestinal | 11 (31) | 7 (19) | 2 (11) | 6 (33) | 26 (24) | |
| Abdominal pain | 5 (14) | 4 (11) | 2 (11) | 3 (17) | 14 (13) | |
| Diarrhea | 7 (19) | 2 (6) | 2 (11) | 3 (17) | 14 (13) | |
| Nausea | 3 (8) | 1 (3) | 1 (6) | 2 (11) | 7 (7) | |
| Respiratory, Thoracic, Mediastinal | 0 (-) | 5 (14) | 0 (-) | 1 (6) | 6 (6) | |
| Pharyngolaryngeal pain | 0 (-) | 2 (6) | 0 (-) | 1 (6) | 3 (3) | |