Table 2. GMC of Hepatitis B Surface Antibodies at Day 196 for Lot-to-Lot Consistency in the Per-Protocol Set 1.
| Statistic | 3A-HBV | ||
|---|---|---|---|
| Lot A (n = 620) | Lot B (n = 622) | Lot C (n = 627) | |
| Participants evaluated, No. | 611 | 610 | 619 |
| GMC, mean (SD)a | 5883.9 (5.4) | 4824.1 (6.3) | 5506.0 (6.0) |
| GMC, median (range) | 12 200.0 (2.1-20 000.0) | 10 700.0 (2.1-20 000.0) | 12 000.0 (2.1-20 000.0) |
| Mean adjusted GMC (SE) [95% CI]b | 5882.3 (1.1) [5112.4-6768.0] | 4821.7 (1.1) [4190.1-5548.4] | 5570.0 (1.1) [4844.63-6403.7] |
| Adjusted GMC ratio (95% CI)b | |||
| Lot A vs lot B | 0.82 (0.67-1.00) | ||
| Lot A vs lot C | 0.95 (0.78-1.15) | ||
| Lot B vs lot C | 1.16 (0.95-1.41) | ||
Abbreviation: GMC, geometric mean concentration.
a
The mean and SD are based on log10-transformed data, then transformed back to hepatitis B surface antibody concentrations.
b
Adjusted GMC, GMC ratio, and corresponding 95% CI were analyzed using analysis of covariance with a factor for vaccine lot group, and a covariate for the log transformed prevaccination (baseline) titer.