Table 3. The GMT ratios among different batches of EV71 vaccine in subjects who were seronegative at baseline on day 56, by treatment and age groups.
Batch number | n | GMT (95% CI) | GMT ratio (95% CI) |
---|---|---|---|
6–11 mo | |||
Batch 1 | 343 | 420.1 (359.8–490.5) | 1.02 (0.82–1.27) |
Batch 2 | 330 | 413.1 (353.7–482.4) | |
Batch 1 | 343 | 420.1 (359.8–490.5) | 0.89 (0.69–1.06) |
Batch 3 | 325 | 489.6 (422.3–567.6) | |
Batch 2 | 330 | 413.1 (353.7–482.4) | 0.84 (0.68–1.05) |
Batch 3 | 325 | 489.6 (422.3–567.6) | |
12–35 mo | |||
Batch 1 | 796 | 401.5 (362.0–445.4) | 0.82 (0.71–0.94) |
Batch 2 | 823 | 492.2 (448.6–540.1) | |
Batch 1 | 796 | 401.5 (362.0–445.4) | 0.75 (0.66–0.87) |
Batch 3 | 813 | 533.6 (486.0–585.8) | |
Batch 2 | 823 | 492.2 (448.6–540.1) | 0.92 (0.81–1.05) |
Batch 3 | 813 | 533.6 (486.0–585.8) | |
Total | |||
Batch 1 | 1139 | 407.0 (373.5–443.6) | 0.87 (0.77–0.98) |
Batch 2 | 1153 | 468.1 (432.2–507.0) | |
Batch 1 | 1139 | 407.0 (373.5–443.6) | 0.78 (0.70–0.88) |
Batch 3 | 1138 | 520.6 (481.2–563.3) | |
Batch 2 | 1153 | 468.1 (432.2–507.0) | 0.90 (0.80–0.99) |
Batch 3 | 1138 | 520.6 (481.2–563.3) |
n, number of subjects. The equivalence margin of GMT is 0.67–1.5. The results were calculated on basis of subjects whom completed the two-dose immune schedule and had their serum detection results at day 56.