Table 1.
Adverse events and reactions after the booster vaccination.
| AE | SCTV01C |
|||
|---|---|---|---|---|
| Saline | 20 μg | 40 μg | Total | |
| (N = 75) | (N = 79) | (N = 80) | (N = 159) | |
| n (%) | n (%) | n (%) | n (%) | |
| TEAEs | 21 (28.0) | 29 (36.7) | 23 (28.8) | 52 (32.7) |
| Vaccine-related TEAEs | 19 (25.3) | 24 (30.4) | 20 (25.0) | 44 (27.7) |
| AEs within 0–7 days | 13 (17.3) | 18 (22.8) | 15 (18.8) | 33 (20.8) |
| AEs within 0–28 days | 19 (25.3) | 23 (29.1) | 20 (25.0) | 43 (27.0) |
| Grade 3 of above AEs | 0 | 0 | 3 (3.8) | 3 (1.9) |
| Grade 3 of Vaccine-related AEs | 0 | 0 | 3 (3.8) | 3 (1.9) |
| Solicited AEs | ||||
| Any | 12 (16.0) | 19 (24.1) | 14 (17.5) | 33 (20.8) |
| Grade ≥3 | 0 | 0 | 3 (3.8) | 3 (1.9) |
| Solicited Local AEs | ||||
| Any | 1 (1.3) | 13 (16.5) | 9 (11.3) | 22 (13.8) |
| Grade ≥3 | 0 | 0 | 0 | 0 |
| Injection site pain | 1 (1.3) | 10 (12.7) | 9 (11.3) | 19 (11.9) |
| Injection site pruritus | 0 | 2 (2.5) | 1 (1.3) | 3 (1.9) |
| Injection site swelling | 0 | 2 (2.5) | 0 | 2 (1.3) |
| Injection site erythema | 0 | 1 (1.3) | 0 | 1 (0.6) |
| Solicited Systemic AEs | ||||
| Any | 11 (14.7) | 8 (10.1) | 6 (7.5) | 14 (8.8) |
| Grade ≥3 | 0 | 0 | 3 (3.8) | 3 (1.9) |
| Pyrexia | 6 (8.0) | 6 (7.6) | 4 (5.0) | 10 (6.3) |
| Headache | 4 (5.3) | 1 (1.3) | 1 (1.3) | 2 (1.3) |
| Fatigue | 0 | 1 (1.3) | 0 | 1 (0.6) |
| Insomnia | 0 | 0 | 1 (1.3) | 1 (0.6) |
| Myalgia | 2 (2.7) | 1 (1.3) | 0 | 1 (0.6) |
| Pruritus | 1 (1.3) | 1 (1.3) | 0 | 1 (0.6) |
| Vaccine-related Solicited AEs | 12 (16.0) | 18 (22.8) | 14 (17.5) | 32 (20.1) |
| Grade ≥3 | 0 | 0 | 3 (3.8) | 3 (1.9) |
| Pyrexia | 0 | 0 | 3 (3.8) | 3 (1.9) |
| Unsolicited AEs | ||||
| Any | 12 (16.0) | 16 (20.3) | 15 (18.8) | 31 (19.5) |
| Grade ≥3 | 0 | 0 | 0 | 0 |
TEAE= treatment-emergent adverse event.