Table 2.
Seroprotection rate at week 4 (mITT population).
HepB-CpG |
HepB-Eng |
HepB-AS04 |
Difference in SPRs (HepB-CpG – HepB-Eng) (95% CI)a | Difference in SPRs (HepB-CpG – HepB-AS04) (95% CI)a | Difference in SPRs (HepB-Eng – HepB-AS04) (95% CI)a | ||||
---|---|---|---|---|---|---|---|---|---|
Visit | Number (n/N) of patients | SPR (95% CI)a | Number (n/N) of patients | SPR (95% CI)a | Number (n/N) of patients | SPR (95% CI)a | |||
Week 4 | 28/53 | 52.8% (38.6, 66.7) | 15/46 | 32.6% (19.5, 48.0) | 22/51 | 43.1% (29.3, 57.8) | 20.2%b (0.5, 38.3) | 9.7%c (–9.5, 28.2) | –10.5% (–29.1, 8.9) |
anti-HBs, antibody to hepatitis B surface antigen; CI, confidence interval; mITT, modified intent-to-treat population; SPR, seroprotection rate.
aExact binomial 95% CI (2-sided) for the percentage of patients.
bStatistically significant difference because lower bound of the 95% CI is >0%.
cNon-inferiority met because lower bound of the 95% CI is greater than –10%.