Table 2.
Adverse reactions within 7 days and overall adverse events within 28 days after vaccination
| Low dose group (n=36) | Middle dose group (n=36) | High dose group (n=36) | Total (N=108) | ||
|---|---|---|---|---|---|
| All adverse reactions within 0–7 days | |||||
| Any | 30 (83%) | 30 (83%) | 27 (75%) | 87 (81%) | |
| Grade 3 | 2 (6%) | 2 (6%) | 6 (17%) | 10 (9%) | |
| Injection site adverse reactions within 0–7 days | |||||
| Pain | 17 (47%) | 20 (56%) | 21 (58%) | 58 (54%) | |
| Induration | 2 (6%) | 1 (3%) | 1 (3%) | 4 (4%) | |
| Redness | 2 (6%) | 1 (3%) | 1 (3%) | 4 (4%) | |
| Swelling | 4 (11%) | 4 (11%) | 0 | 8 (7%) | |
| Itch | 2 (6%) | 3 (8%) | 0 | 5 (5%) | |
| Muscular weakness | 0 | 0 | 1 (3%) | 1 (1%) | |
| Systemic adverse reactions within 0–7 days | |||||
| Fever | 15 (42%) | 15 (42%) | 20 (56%) | 50 (46%) | |
| Grade 3 fever | 2 (6%) | 2 (6%) | 5 (14%) | 9 (8%) | |
| Headache | 14 (39%) | 11 (31%) | 17 (47%) | 42 (39%) | |
| Fatigue | 17 (47%) | 14 (39%) | 16 (44%) | 47 (44%) | |
| Grade 3 fatigue | 0 | 0 | 2 (6%) | 2 (2%) | |
| Vomiting | 1 (3%) | 0 | 1 (3%) | 2 (2%) | |
| Diarrhoea | 3 (8%) | 4 (11%) | 5 (14%) | 12 (11%) | |
| Muscle pain | 7 (19%) | 3 (8%) | 8 (22%) | 18 (17%) | |
| Grade 3 muscle pain | 0 | 0 | 1 (3%) | 1 (1%) | |
| Joint pain | 2 (6%) | 2 (6%) | 5 (14%) | 9 (8%) | |
| Grade 3 joint pain | 0 | 0 | 1 (3%) | 1 (1%) | |
| Throat pain | 1 (3%) | 3 (8%) | 4 (11%) | 8 (7%) | |
| Cough | 1 (3%) | 2 (6%) | 3 (8%) | 6 (6%) | |
| Nausea | 2 (6%) | 1 (3%) | 3 (8%) | 6 (6%) | |
| Functional GI disorder | 1 (3%) | 0 | 0 | 1 (1%) | |
| Dyspnoea | 0 | 0 | 2 (6%) | 2 (2%) | |
| Grade 3 dyspnoea | 0 | 0 | 1 (3%) | 1 (1%) | |
| Appetite impaired | 6 (17%) | 5 (14%) | 6 (17%) | 17 (16%) | |
| Dizziness | 1 (3%) | 0 | 1 (3%) | 2 (2%) | |
| Mucosal abnormality | 0 | 0 | 1 (3%) | 1 (1%) | |
| Pruritus | 1 (3%) | 1 (3%) | 1 (3%) | 3 (3%) | |
| Overall adverse events within 0–28 days | |||||
| Any | 31 (86%) | 30 (83%) | 27 (75%) | 88 (81%) | |
| Grade 3 | 2 (6%) | 2 (6%) | 6 (17%) | 10 (9%) | |
Data are n (%). Any refers to all the participants with any grade adverse reactions or events. Adverse reactions and events were graded according to the scale issued by the China State Food and Drug Administration. Grade 3=severe (ie, prevented activity). GI=gastrointestinal.