Table 1. Baseline demographic characteristics of the HBsAg (+) and HBsAg (-) participants.
| Vaccine | Placebo | P value# | |||
|---|---|---|---|---|---|
| HBsAg (+) | HBsAg (-) | HBsAg (+) | HBsAg (-) | ||
| All participants (Safety analysis set) | 406 | 6629 | 424 | 6606 | |
| Age (SD) | 43.95 (10.99) | 44.39 (11.31) | 45.31 (10.41) | 44.36 (11.36) | P1 = 0.4375, P2 = 0.0668 |
| Men (%) | 186 (45.81) | 2711 (40.90) | 199 (46.93) | 2739 (41.46) | P1 = 0. 0507, P2 = 0.7461 |
| Positive anti-HEV (prevalence) | 183 (45.07) | 3158 (48.03) | 211 (49.76) | 3060 (46.32) | P1 = 0. 3150, P2 = 0.1762 |
| GMC (95%CI) (Wu/mL)* | 0.53 (0.44–0.63) | 0.54 (0.51–0.56) | 0.65 (0.55–0.77) | 0.52 (0.50–0.54) | P1 = 0.8915, P2 = 0.0936 |
| Immunogenicity analysis set | 309 | 5258 | 340 | 5256 | |
| Age (SD) | 44.73 (10.87) | 45.25 (10.74) | 46.02 (9.93) | 45.20 (10.87) | P1 = 0.4102, P2 = 0.1150 |
| Men (%) | 135 (43.69) | 2036 (38.72) | 146 (42.94) | 2059 (39.17) | P1 = 0.0819, P2 = 0.8476 |
| Reactogenicity subset | 95 | 1220 | 116 | 1210 | |
| Age (SD) | 42.92 (11.90) | 44.83 (11.17) | 44.89 (11.23) | 44.95 (11.09) | P1 = 0.1097, P2 = 0.2181 |
| Men (%) | 45 (47.37) | 478 (39.18) | 59 (50.86) | 501 (41.40) | P1 = 0.1163, P2 = 0.6135 |
*
GMC: Geometric mean concentration of anti-HEV IgG. #P1-Between Hecolin® Group HBsAg (+) and Hecolin® Group HBsAg (-); P2-Between Hecolin® Group HBsAg (+) and Control Group HBsAg (+).