Table 3.
AEs within a month after vaccination in stage 2.
| 5-dose PVRV-WIBP (n = 651) |
5-dose PVRV-LNCD (n = 652) |
4-dose PVRV-WIBP (n = 652) |
p-value (Fisher) |
|
|---|---|---|---|---|
| Total | ||||
| Grade 1 | 282 (43.32%) | 256 (39.26%) | 408(62.58%) | <.0001 |
| Grade 2 | 75 (11.52%) | 41 (6.29%) | 163(25.00%) | |
| Grade 3 | 2 (0.31%) | 2 (0.31%) | 6(0.92%) | |
| Local AEs | ||||
| Grade 1 | 175 (26.88%) | 154 (23.62%) | 243 (37.27%) | <.0001 |
| Grade 2 | 25 (3.84%) | 15 (2.30%) | 56 (8.59%) | |
| Grade 3 | 1 (0.15%) | 2 (0.31%) | 1 (0.15%) | |
| Pain | 170 (26.11%) | 152 (23.31%) | 264 (40.03) | <.0001 |
| Swelling | 19 (2.92%) | 20 (3.07%) | 25 (3.83%) | .6215 |
| Redness | 19 (2.92%) | 16 (2.45%) | 14 (2.15%) | .6515 |
| Itching | 12 (1.84%) | 4 (0.61%) | 17 (2.61%) | .0119 |
| Induration | 3 (0.46) | 1 (0.15%) | 1 (0.15%) | .4640 |
| System AEs | ||||
| Grade 1 | 192 (29.49%) | 150 (23.01%) | 283 (43.40%) | <.0001 |
| Grade 2 | 55 (8.45%) | 29 (4.45%) | 132 (20.25%) | |
| Grade 3 | 1 (0.15%) | 0 (0.00%) | 5 (0.77%) | |
| Fever | 156 (23.96%) | 110 (16.87%) | 261 (40.03%) | <.0001 |
| Fatigue | 60 (9.22%) | 38 (5.83%) | 113 (17.33%) | <.0001 |
| Headache | 52 (7.99%) | 30 (4.60%) | 93 (14.26%) | <.0001 |
| Myalgia | 16 (2.46%) | 9 (1.38%) | 42 (6.44%) | <.0001 |
| Nausea and vomiting | 7 (1.08%) | 17 (2.61%) | 20 (3.07%) | .0301 |
| Arthrodynia | 6 (0.92%) | 5 (0.77%) | 14 (2.15%) | .0723 |
| Allergies | 5 (0.77%) | 5 (0.77%) | 9 (1.38%) | .4644 |
| Unsolicited AEs | 15 (2.30%) | 17 (2.61%) | 18 (2.76%) | .7987 |
AE, adverse effects.