Table 2.
Solicited and unsolicited adverse reactions that occurred within 28 d after vaccination
| Group A (two doses primed + Convidecia, n = 96) | Group B (two doses primed + CoronaVac, n = 102) | P value | Group C (one dose primed + Convidecia, n = 51) | Group D (one dose primed + CoronaVac, n = 50) | P value | ||
|---|---|---|---|---|---|---|---|
| Solicited adverse reactions within 28 d | |||||||
| Any | 33 (34.4) | 5 (4.9) | <0.0001 | 13 (25.5) | 4 (8.0) | 0.0188 | |
| Severe | 2 (2.1) | 0 (0.0) | 0.2338 | 0 (0.0) | 0 (0.0) | – | |
| Injection site adverse reactions | |||||||
| Total | Any | 28 (29.2) | 3 (2.9) | <0.0001 | 12 (23.5) | 1 (2.0) | 0.0012 |
| Severe | 2 (2.1) | 0 (0.0) | 0.2338 | 0 (0.0) | 0 (0.0) | – | |
| Pain | Any | 25 (26.0) | 3 (2.9) | <0.0001 | 10 (19.6) | 1 (2.0) | 0.0045 |
| Severe | 2 (2.1) | 0 (0.0) | 0.2338 | 0 (0.0) | 0 (0.0) | – | |
| Induration | Any | 9 (9.4) | 0 (0.0) | 0.0012 | 4 (7.8) | 0 (0.0) | 0.1176 |
| Redness | Any | 12 (12.5) | 0 (0.0) | 0.0002 | 5 (9.8) | 0 (0.0) | 0.0564 |
| Swelling | Any | 9 (9.4) | 0 (0.0) | 0.0012 | 5 (9.8) | 0 (0.0) | 0.0564 |
| Itch | Any | 10 (10.4) | 0 (0.0) | 0.0025 | 5 (9.8) | 0 (0.0) | 0.0564 |
| Systemic adverse reactions | |||||||
| Total | Any | 14 (14.6) | 3 (2.9) | 0.0035 | 6 (11.8) | 3 (6.0) | 0.4874 |
| Fever | Any | 4 (4.2) | 0 (0.0) | 0.0535 | 3 (5.9) | 1 (2.0) | 0.6175 |
| Headache | Any | 2 (2.1) | 0 (0.0) | 0.2338 | 1 (2.0) | 0 (0.0) | >0.9999 |
| Fatigue | Any | 11 (11.5) | 3 (2.9) | 0.0195 | 4 (7.8) | 2 (4.0) | 0.6779 |
| Diarrhea | Any | 0 (0.0) | 1 (1.0) | >0.9999 | 0 (0.0) | 0 (0.0) | – |
| Muscle pain | Any | 1 (1.0) | 0 (0.0) | 0.4848 | 1 (2.0) | 0 (0.0) | >0.9999 |
| Joint pain | Any | 1 (1.0) | 1 (1.0) | >0.9999 | 0 (0.0) | 0 (0.0) | – |
| Throat pain | Any | 1 (1.0) | 1 (1.0) | >0.9999 | 0 (0.0) | 0 (0.0) | – |
| Cough | Any | 0 (0.0) | 0 (0.0) | – | 1 (2.0) | 0 (0.0) | >0.9999 |
| Nausea | Any | 0 (0.0) | 0 (0.0) | – | 1 (2.0) | 0 (0.0) | >0.9999 |
| Unsolicited adverse reactions within 28 d | |||||||
| Total | Any | 1 (1.0) | 0 (0.0) | 0.4848 | 0 (0.0) | 0 (0.0) | – |
| Dizziness | Any | 1 (1.0) | 0 (0.0) | 0.4848 | 0 (0.0) | 0 (0.0) | – |
| Muscle pain | Any | 1 (1.0) | 0 (0.0) | 0.4848 | 0 (0.0) | 0 (0.0) | – |
Data are n (%). n, number of participants; %, proportion of participants; any, all participants with any grade of adverse reactions or event. The analysis was based on the intervention modified intention-to-treat cohort. P values shown in bold are <0.05.