Table 3.
Adverse events in the safety analysis population
| Event | Treatment vaccine N = 830 | Control vaccine N = 830 | p value |
|---|---|---|---|
| Serious adverse events(no. of participants) | |||
| Events within 7 d after injection | 1(0.12%) | 0(0%) | 1.0000 |
| Events from day 8 to day 30 | 2 (0.24%) | 2 (0.24%) | 1.0000 |
| Solicited adverse reactions within 7 d after an injection(no. of participants) | |||
| Any | 285(34.34%) | 296(35.66%) | 0.6069 |
| Grade 3 | 20(2.41%) | 19(2.29%) | 1.0000 |
| Injection-site reactions | |||
| Pain | |||
| Any | 201(24.22%) | 202(24.34%) | 1.0000 |
| Grade 3 | 0(0.00%) | 0(0.00%) | 1.0000 |
| Redness | |||
| Any | 50(6.02%) | 62(7.47%) | 0.2817 |
| Grade 3 | 10(1.20%) | 12(1.45%) | 0.9320 |
| Swelling | |||
| Any | 44(5.30%) | 53(6.39%) | 0.4026 |
| Grade 3 | 10(1.20%) | 13(1.57%) | 0.8360 |
| Pruritus | |||
| Any | 20(2.41%) | 15(1.81%) | 0.4949 |
| Grade 3 | 0(0.00%) | 0(0.00%) | 1.0000 |
| Induration | |||
| Any | 1(0.12%) | 0(0.00%) | 1.0000 |
| Grade 3 | 0(0.00%) | 0(0.00%) | 1.0000 |
| Systemic reactions | |||
| Fever | |||
| Any | 82(9.88%) | 88(10.60%) | 0.6282 |
| Grade 3 | 3(0.36%) | 1(0.12%) | 0.3549 |
| Headache | |||
| Any | 24(2.89%) | 32(3.98%) | 0.2808 |
| Grade 3 | 0(0.00%) | 0(0.00%) | 1.0000 |
| Fatigue | |||
| Any | 30(3.61%) | 30(3.61%) | 1.0000 |
| Grade 3 | 0(0.00%) | 0(0.00%) | 1.0000 |
| Nausea or vomiting | |||
| Any | 6(0.72%) | 12(1.45%) | 0.2353 |
| Grade 3 | 0(0.00%) | 0(0.00%) | 1.0000 |
| Diarrhea | |||
| Any | 9(1.08%) | 10(1.20%) | 1.0000 |
| Grade 3 | 1(0.12%) | 1(0.12%) | 1.0000 |
| Rash | |||
| Any | 5(0.60%) | 7(0.84%) | 0.7736 |
| Grade 3 | 0(0.00%) | 0(0.00%) | 1.0000 |
| Allergy | |||
| Any | 2(0.24%) | 1(0.12%) | 1.0000 |
| Grade 3 | 1(0.12%) | 0(0.00%) | 1.0000 |