Table 2.
Incidence of AEs post vaccination.
| HRV (3198 subjects) |
placebo (3193 subjects) |
||||
|---|---|---|---|---|---|
| Cases | Incidence ∗ (%) | Cases | Incidence∗ (%) | P-value | |
| AE | 2484 | 77.67 | 2418 | 75.73 | 0.0666 |
| Solicited AE | 2134 | 66.73 | 2056 | 64.39 | 0.0514 |
| Unsolicited AE | 1267 | 39.62 | 1292 | 40.46 | 0.4908 |
| Vaccine-related AE | 2147 | 67.14 | 2062 | 64.58 | 0.0326 |
| Solicited AE | 2134 | 66.73 | 2056 | 64.39 | 0.0514 |
| Unsolicited AE | 74 | 2.31 | 52 | 1.63 | 0.0584 |
AE: adverse events. Incidence = number of cases/number of subjects. All events were collected within 28 days after each dose.