Table 3. Analysis of SPR 4 Weeks After the Third Injection at Study Day 196a.
| Parameter | 1A-HBV (n = 603) | Pooled 3A-HBV (n = 1778) |
|---|---|---|
| Participants evaluated, No. | 592 | 1753 |
| Participants who achieved seroprotection, No. | 561 | 1740 |
| SPR, % (95% CI)b | 94.8 (92.7-96.4) | 99.3 (98.7-99.6) |
| Estimated difference in SPR (95% CI)c | 4.5 (2.9-6.6) | |
Abbreviation: SPR, seroprotection rate.
a
Seroprotection was defined as a hepatitis B surface antibody concentration of at least 10 mIU/mL in serum.
b
Exact (Clopper-Pearson) 2-sided CI based on the observed proportion of participants.
c
The estimated difference in proportions and 2-sided 95% CIs were calculated using the Miettinen and Nurminen method.