Table 1.
Safety profile.
| No. of participants with event or reaction (%) |
|||
|---|---|---|---|
| Vaccine (N=6000) | Placebo (N=6000) | P | |
| AE | 3878 (64.63) | 3759 (62.65) | 0.025* |
| AE D28 | 3794 (63.23) | 3595 (59.92) | <0.001*** |
| Solicited AE D7 | 2759 (45.98) | 2287 (38.12) | <0.001*** |
| Systemic AE D7 | 2657 (44.28) | 2237 (37.28) | <0.001*** |
| Local AE D7 | 354 (5.90) | 136 (2.27) | <0.001*** |
| Unsolicited AE D28 | 2507 (41.78) | 2563 (42.72) | 0.309 |
| Serious AE | 68 (1.13) | 125 (2.08) | <0.001*** |
| AR | 2195 (36.58) | 1584 (26.40) | <0.001*** |
| AR D28 | 2195 (36.58) | 1583 (26.38) | <0.001*** |
| Solicited AR D7 | 2161 (36.02) | 1554 (25.90) | <0.001*** |
| Systemic AR D7 | 2022 (33.70) | 1491 (24.85) | <0.001*** |
| Local AR D7 | 352 (5.87) | 135 (2.25) | <0.001*** |
| Unsolicited AR D28 | 122 (2.03) | 89 (1.48) | 0.026* |
| Serious AR | 2 (0.03) | 2 (0.03) | 1.000 |
| HFMD | 197 (3.28) | 388 (6.47) | <0.001*** |
| Hospitalization | 67 (1.12) | 125 (2.08) | <0.001*** |
| Hospitalized for HFMD | 41 (0.68) | 88 (1.47) | <0.001*** |
AE: adverse event; AR: adverse reaction; D7: within 7 days; D28: within 28 days; HFMD: hand-foot-mouth disease.
*
P < 0.05;
***
P < 0.001.
#
Fisher exact test was used for categorical data.