Table 5. Comparison of GMT, seroprotection, percentage of subjects with increasing antibody titer ≥4 times, and/or percentage of subjects with transition of seronegative to seropositive following primary series of investigational product compare to control.
| Description | Pre-vaccination | Post-vaccination | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 0118S (n=131) | 0218S (n=133) | 0318S (n=127) | 0318 (n=130) | p-value | 0118S (n=131) | 0218S (n=133) | 0318S (n=127) | 0318 (n=130) | p-value | ||
| GMT (IU/mL) | 0.41* | 1.609e-13 (p<0.001) | |||||||||
| Mean | 1.376 | 2.119 | 2.373 | 2.119 | 4,088.826 | 8,214.546 | 5,154.18 | 1,520.126 | |||
| (95% CI) | (0.823–2.302) | (1.365–3.287) | (1.398–4.027) | (1.232–3.645) | (3,107.157–5,380.643) | (6,032.561–11,185.758) | (3,752.066–7,080.253) | (1,105.294–2,090.651) | |||
| Anti-HbsAg ≥10 b | 0.8782 | 0.8714 | |||||||||
| No. | 32 | 34 | 35 | 37 | 131 | 132 | 127 | 129 | |||
| %SP | 24.427 | 25.564 | 27.559 | 28.462 | 100 | 99.248 | 100 | 99.231 | |||
| p-value (compared to group B) | 0.46 | 0.597 | 0.872 | 0.997 | 0.987 | 0.997 | - | ||||
| Increasing antibody titer ≥4 times | 0.029 | ||||||||||
| No. | - | - | - | - | - | 131 | 133 | 127 | 127 | ||
| %SC | - | - | - | - | - | 100 | 100 | 100 | 97.69 | ||
| p-value (compared to group B) | - | - | - | - | - | 0.748 | 0.913 | 0.799 | - | ||
| Transition of seronegative to seropositive | 0.8452 | ||||||||||
| No. | - | - | - | - | - | 99 | 92 | 92 | 92 | ||
| %SC | - | - | - | - | - | 100 | 98.99 | 100 | 98.925 | ||
GMT, geometric mean titer; CI, confidence interval; HBsAg, hepatitis B surface antigen; %SP, seroprotection rate; %SC, seroconversion rate.