Table 2. Adverse reactions/events after vaccination with Hecolin® in the HBsAg (+) and HBsAg (-) participants.
| Vaccine | Placebo | P value* | |||
|---|---|---|---|---|---|
| HBsAg (+) | HBsAg (-) | HBsAg (+) | HBsAg (-) | ||
| Participants in the reactogenicity subset | 95 | 1,220 | 116 | 1210 | |
| Solicited local adverse events within 72 h | |||||
| All | 11 (11.58%) | 166 (13.61%) | 5 (4.31%) | 89 (7.36%) | P1 = 0.5770, P2 = 0.0472 |
| ≥ Grade 3 | 0 (0.00%) | 2 (0.16%) | 0 (0.00%) | 0 (0.00%) | P1 = 1.0000, P2 = 1.0000 |
| Solicited systemic adverse events within 72 h | |||||
| All | 21 (22.11%) | 246 (20.16%) | 13 (11.21%) | 250 (20.66) | P1 = 0.6505, P2 = 0.0322 |
| ≥ Grade 3 | 0 (0.00%) | 7 (0.57%) | 1 (0.86%) | 3 (0.25%) | P1 = 1.0000, P2 = 1.0000 |
| Participants not in the reactogenicity subset | 311 | 5409 | 308 | 5396 | |
| Solicited local adverse events within 72 h | |||||
| All | 6 (1.93%) | 106 (1.96%) | 2 (0.65%) | 53 (0.98%) | P1 = 0.9699, P2 = 0.2859 |
| ≥ Grade 3 | 1 (0.32%) | 10 (0.18%) | 0 (0.00%) | 5 (0.09%) | P1 = 0.4596, P2 = 1.0000 |
| Solicited systemic adverse events within 72 h | |||||
| All | 4 (1.29%) | 96 (1.77%) | 3 (0.97%) | 91 (1.69%) | P1 = 0.5226, P2 = 1.0000 |
| ≥ Grade 3 | 1 (0.32%) | 7 (0.13%) | 0 (0.00%) | 9 (0.17%) | P1 = 0.3608, P2 = 1.0000 |
| Participants in the whole vaccinated cohort | 406 | 6629 | 424 | 6606 | |
| Unsolicited events within 30 d | |||||
| All | 39 (9.61%) | 707 (10.67%) | 40 (9.43%) | 748 (11.32%) | P1 = 0.5010, P2 = 0.9328 |
| ≥ Grade 3 | 2 (0.49%) | 84 (1.27%) | 3 (0.71%) | 80 (1.21%) | P1 = 0.2407, P2 = 1.0000 |
| SAEs during the period from month 0 to month 31 | |||||
| All | 29 (7.14%) | 366 (5.52%) | 25 (5.90%) | 359 (5.43%) | P1 = 0.1683, P2 = 0.4667 |
*
P1-Between Hecolin® Group HBsAg (+) and Hecolin® Group HBsAg (-); P2-Between Hecolin® Group HBsAg (+) and Control Group HBsAg (+).