Table 2.
Adverse events and reactions after the booster vaccination.
| AE | SCTV01C |
||||
|---|---|---|---|---|---|
| Saline (N = 75) n (%) |
20 μg (N = 79) n (%) |
40 μg (N = 80) n (%) |
Total (N = 159) n (%) |
p valuea | |
| TEAEs | 26 (34.7) | 32 (40.5) | 31 (38.8) | 63 (39.6) | 0.7431 |
| Vaccine-related TEAEs | 22 (29.3) | 30 (38.0) | 22 (27.5) | 52 (32.7) | |
| AEs within 0–7 days | 11 (14.7) | 18 (22.8) | 13 (16.3) | 31 (19.5) | |
| AEs within 0–28 days | 22 (29.3) | 30 (38.0) | 22 (27.5) | 52 (32.7) | |
| Grade ≥3 AEs | 0 | 1 (1.3) | 0 | 1 (0.6) | |
| Grade ≥3 vaccine-related AEs | 0 | 1 (1.3) | 0 | 1 (0.6) | |
| Solicited AEs | |||||
| Any | 10 (13.3) | 20 (25.3) | 13 (16.3) | 33 (20.8) | 0.1416 |
| Grade ≥3 | 0 | 0 | 0 | 0 | |
| Solicited local AEs | |||||
| Any | 2 (2.7) | 11 (13.9) | 8 (10.0) | 19 (11.9) | 0.0373 |
| Grade ≥3 | 0 | 0 | 0 | 0 | |
| Injection site pain | 2 (2.7) | 10 (12.7) | 7 (8.8) | 17 (10.7) | |
| Injection site pruritus | 0 | 1 (1.3) | 1 (1.3) | 2 (1.3) | |
| Injection site swelling | 0 | 0 | 2 (2.5) | 2 (1.3) | |
| Injection site erythema | 0 | 0 | 1 (1.3) | 1 (0.6) | |
| Injection site induration | 0 | 0 | 1 (1.3) | 1 (0.6) | |
| Solicited systemic AEs | |||||
| Any | 8 (10.7) | 11 (13.9) | 6 (7.5) | 17 (10.7) | 0.4313 |
| Grade ≥3 | 0 | 0 | 0 | 0 | |
| Pyrexia | 6 (8.0) | 6 (7.6) | 4 (5.0) | 10 (6.3) | |
| Cough | 0 | 2 (2.5) | 2 (2.5) | 4 (2.5) | |
| Headache | 2 (2.7) | 2 (2.5) | 0 | 2 (1.3) | |
| Constipation | 0 | 1 (1.3) | 0 | 1 (0.6) | |
| IP-related solicited AEs | 9 (12.0) | 18 (22.8) | 12 (15.0) | 30 (18.9) | 0.1826 |
| Unsolicited AEs | 21 (28.0) | 17 (21.5) | 21 (26.3) | 38 (23.9) | 0.6532 |
| Vaccine-related unsolicited AEs | 14 (18.7) | 15 (19.0) | 12 (15.0) | 27 (17.0) | |
| Pyrexia | 2 (2.7) | 4 (5.1) | 3 (3.8) | 7 (4.4) | |
| CPK increased | 1 (1.3) | 3 (3.8) | 2 (2.5) | 5 (3.1) | |
| Glycosuria | 2 (2.7) | 0 | 4 (5.0) | 4 (2.5) | |
| Headache | 0 | 1 (1.3) | 3 (3.8) | 4 (2.5) | |
| SAEs | 0 | 0 | 0 | 0 | |
| AESI | 1 (1.3) | 0 | 0 | 0 | |
AESI = adverse event of special interest; CPK = creatine phosphokinase; IP = investigational product; SAE = serious adverse event; TEAE = treatment-emergent adverse event.
a
Statistical comparison of AEs between saline and total SCTV01C.