Table 3.
GMT of Anti-Vi IgG response for overall age strata (Immunogenicity Set)
| Vi-DT dose | Time point |
Vi-DT Group |
Comparator Group |
P-value† | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any dose | Single dose | two-dose | ||||||||||||||
| N | GMTa (95% CI) | SD | N | GMTa (95% CI) | SD | N | GMTa (95% CI) | SD | N | GMTa (95% CI) | SD | |||||
| First Dose | Day 0 | 228 | 0.35 (0.30, 0.41) |
1.20 | 114 | 0.32 (0.26, 0.41) |
1.12 | 114 | 0.38 (0.30, 0.47) |
1.28 | 57 | 0.43 (0.31, 0.59) |
1.42 | – | ||
| Week 4 | 228 | 444.38 (401.70, 491.60) |
0.68 | 114 | 420.03 (364.16,484.49) | 0.69 | 114 | 470.14 (407.60,542.29) | 0.67 | 57 | 0.41 (0.34, 0.50) |
1.16 | – | |||
| Second Dose | Week 24 | 222 | 41.54 (37.13,46.48) | 0.77 | 112 | 36.82 (31.47,43.08) | 0.80 | 110 | 46.99 (40.10,55.06) | 0.72 | 55 | 0.53 (0.42, 0.66) |
1.27 | – | ||
| Week 28 | 221 | 74.98 (62.21,90.38) | 1.36 | 112 | 28.70 (23.37,35.25) | 0.86 | 109 | 201.28 (163.41,247.92) | 1.04 | 55 | 0.61 (0.46, 0.82) |
1.60 | <.0001[1] | |||
N – total number tested; 95% CI – 95% confidence interval; SD – Standard deviation
a
Geometric Mean Titers (unit: IU/ml); [1] GMT of Anti-Vi IgG ELISA Response at Week 28 (Single-dose vs• Two-dose);
†
P-values for comparison of GMTs was adjusted for age strata in the model; The ratio (95% CI) of GMT of Anti-Vi IgG ELISA Response at Week 4 of single-dose group vs. Week 28 of two-dose group is 2•08 (1•66, 2•61)