Table 3.
Adverse reactions within 7 days and overall adverse events within 30 days after vaccination in phase 2 trial
| Adult group | Elderly group | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Low dose (0, 21 days n = 100) | High dose (0, 21 days n = 100) | Low dose (0, 14, 28 days n = 100) | High dose (0, 14, 28 days n = 100) | Placebo (n = 80) | p value | Low dose (0, 21 days n = 100) | High dose (0, 21 days n = 100) | Low dose (0, 14, 28 days n = 100) | High dose (0, 14, 28 days n = 99) | Placebo (n = 80) | p value | |
| Solicited adverse reactions within 7 days | ||||||||||||
| Any | 16 (16%) | 19 (19%) | 22 (22%) | 30 (30%) | 16 (20%) | 0.16 | 10 (10%) | 12 (12%) | 18 (18%) | 16 (16%) | 3 (4%) | 0.04 |
| Grade ≥3 | 0 (0%) | 0 (0%) | 0 (0%) | 1 (1%) | 0 (0%) | >0.99 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | – |
| Solicited injection site adverse reactions within 7 days | ||||||||||||
| Any | 6 (6%) | 16 (16%) | 13 (13%) | 25 (25%) | 11 (14%) | 0.01 | 4 (4%) | 9 (9%) | 10 (10%) | 8 (8%) | 1 (1%) | 0.10 |
| Pain | 6 (6%) | 15 (15%) | 6 (6%) | 16 (16%) | 10 (13%) | 0.05 | 4 (4%) | 9 (9%) | 8 (8%) | 5 (5%) | 1 (1%) | 0.16 |
| Itch | 0 (0%) | 1 (1%) | 8 (8%) | 13 (13%) | 1 (1%) | <0.01 | 0 (0%) | 1 (1%) | 3 (3%) | 3 (3%) | 0 (0%) | 0.20 |
| Swelling | 0 (0%) | 0 (0%) | 7 (7%) | 4 (4%) | 0 (0%) | <0.01 | – | – | – | – | – | – |
| Induration | 0 (0%) | 1 (1%) | 3 (3%) | 3 (3%) | 1 (1%) | 0.40 | – | – | – | – | – | – |
| Redness | 0 (0%) | 0 (0%) | 3 (3%) | 3 (3%) | 0 (0%) | 0.05 | – | – | – | – | – | – |
| Rash | 0 (0%) | 0 (0%) | 1 (1%) | 0 (0%) | 0 (0%) | >0.99 | – | – | – | – | – | – |
| Solicited systematic adverse reactions within 7 days | ||||||||||||
| Any | 12 (12%) | 7 (7%) | 10 (10%) | 9 (9%) | 6 (8%) | 0.76 | 6 (6%) | 3 (3%) | 12 (12%) | 10 (10%) | 2 (3%) | 0.03 |
| Cough | 3 (3%) | 0 (0%) | 2 (2%) | 3 (3%) | 4 (5%) | 0.25 | 1 (1%) | 0 (0%) | 3 (3%) | 2 (2%) | 1 (1%) | 0.47 |
| Fatigue | 2 (2%) | 2 (2%) | 5 (5%) | 1 (1%) | 0 (0%) | 0.22 | 1 (1%) | 0 (0%) | 1 (1%) | 1 (1%) | 0 (0%) | 0.95 |
| Fever | 4 (4%) | 2 (2%) | 2 (2%) | 2 (2%) | 0 (0%) | 0.52 | 0 (0%) | 1 (1%) | 2 (2%) | 3 (3%) | 0 (0%) | 0.27 |
| Headache | 3 (3%) | 2 (2%) | 3 (3%) | 1 (1%) | 0 (0%) | 0.58 | 1 (1%) | 1 (1%) | 2 (2%) | 3 (3%) | 0 (0%) | 0.64 |
| Sore throat | 0 (0%) | 0 (0%) | 3 (3%) | 3 (3%) | 2 (3%) | 0.14 | 2 (2%) | 1 (1%) | 1 (1%) | 0 (0%) | 0 (0%) | 0.81 |
| Nausea | 2 (2%) | 4 (4%) | 1 (1%) | 1 (1%) | 0 (0%) | 0.33 | 0 (0%) | 0 (0%) | 3 (3%) | 2 (2%) | 1 (1%) | 0.19 |
| Joint pain | 0 (0%) | 0 (0%) | 2 (2%) | 2 (2%) | 1 (1%) | 0.44 | 0 (0%) | 0 (0%) | 1 (1%) | 2 (2%) | 0 (0%) | 0.28 |
| Diarrhea | 3 (3%) | 0 (0%) | 1 (1%) | 0 (0%) | 0 (0%) | 0.16 | 1 (1%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | >0.99 |
| Vomit | – | – | – | – | – | – | 0 (0%) | 0 (0%) | 2 (2%) | 1 (1%) | 0 (0%) | 0.36 |
| Anorexia | – | – | – | – | – | – | 1 (1%) | 0 (0%) | 1 (1%) | 0 (0%) | 0 (0%) | >0.99 |
| Adverse reactions within 7 days after the first dose | ||||||||||||
| Any | 13 (13%) | 20 (20%) | 4 (4%) | 11 (11%) | 9 (11%) | 0.01 | 8 (8%) | 8 (8%) | 7 (7%) | 7 (7%) | 4 (5%) | 0.94 |
| Grade ≥3 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | – | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | – |
| Adverse reactions within 7 days after the second dose | ||||||||||||
| Any | 5 (5%) | 9 (9%) | 5 (5%) | 11 (11%) | 7 (9%) | 0.41 | 4 (4%) | 6 (6%) | 7 (7%) | 6 (6%) | 3 (4%) | 0.83 |
| Grade ≥3 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | – | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | – |
| Adverse reactions within 7 days after the third dose | ||||||||||||
| Any | – | – | 16 (16%) | 21 (21%) | – | – | – | – | 8 (8%) | 9 (9%) | – | – |
| Grade ≥3 | – | – | 0 (0%) | 0 (0%) | – | – | – | – | 0 (0%) | 0 (0%) | – | – |
| Overall adverse events within 30 days | ||||||||||||
| Any | 30 (30%) | 37 (37%) | 31 (31%) | 41 (41%) | 23 (29%) | 0.32 | 19 (19%) | 26 (26%) | 32 (32%) | 28 (28%) | 14 (18%) | 0.11 |
| Grade ≥3 | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | – | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | – |
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.