Table 4.
Total anti-SE36 IgG antibody.
| Cohort 1 | ||||||
|---|---|---|---|---|---|---|
| BK-SE36 Intramuscular | BK-SE36 Subcutaneous | Control (Synflorix® + saline) Intramuscular | ||||
| n | GMT (95% CI) | n | GMT (95% CI) | n | GMT (95% CI) | |
| Day 0 | 18 | 9.4 (6.7, 13.0) | 18 | 15.1 (8.0, 28.8) | 18 | 16.6 (7.2, 38.5) |
| Day 28 | 18 | 18.2 (10.0, 33.1) | 18 | 29.7 (15.7, 55.9) | 18 | 29.7 (13.8, 63.9) |
| Day 56 | 18 | 97.2 (47.0, 200.9) | 18 | 110.6 (63.6, 192.4) | 18 | 28.5 (13.7, 59.3) |
| Day 182 | 17 | 33.1 (19.1, 57.3) | 18 | 43.4 (23.5, 80.1) | 18 | 28.5 (13.8, 58.9) |
| Day 210 | 17 | 155.3 (79.2, 304.6) | 18 | 169.5 (92.6, 310.2) | 18 | 24.0 (11.4, 50.5) |
| Day 365 | 17 | 27.9 (12.9, 60.4) | 18 | 37.7 (20.5, 69.2) | 17 | 18.0 (8.8, 37.0) |
| Day 477 | 17 | 38.3 (16.2, 90.7) | 18 | 56.0 (27.5, 113.8) | 17 | 43.4 (19.3, 98.0) |
| Cohort 2 | ||||||
| Day 0 | 18 | 16.9 (9.9, 28.6) | 18 | 24.9 (13.3, 46.9) | 18 | 20.6 (11.6, 36.4) |
| Day 28 | 18 | 65.6 (38.0, 113.4) | 18 | 63.7 (37.6, 107.8) | 18 | 27.5 (15.2, 49.9) |
| Day 56 | 17 | 271.7 (144.5, 510.9) | 16 | 304.0 (148.0, 624.6) | 18 | 16.6 (10.4, 26.5) |
| Day 182 | 18 | 21.8 (10.7, 44.7) | 17 | 29.4 (18.2, 47.6) | 18 | 8.7 (7.6, 9.8) |
| Day 210 | 18 | 634.6 (284.3, 1416) | 16 | 640.2 (374.8, 1093) | 18 | 8.4 (7.6, 9.4) |
| Day 365 | 18 | 109.0 (50.3, 235.9) | 16 | 93.9 (39.8, 221.2) | 18 | 22.2 (13.4, 36.8) |
| Day 477 | 18 | 98.9 (39.7, 245.9) | 16 | 38.6 (20.5, 72.9) | 17 | 12.8 (8.9, 18.5) |
Subjects were vaccinated at Day 0, 28 and 182; Day 28, 56 and 210 = 4 weeks after Dose1, 2, and 3, respectively; GMT = geometric mean titre (95% confidence interval); n = number of subjects;
Cohort 1: p = 0.50 for comparison of BK-SE36 arms at Day 182 (prior to Dose 3) and p = 0.83 for comparison of BK-SE36 arms at Day 210 (4 weeks post Dose 3).
Cohort 2: p = 0.48 for comparison of BK-SE36 arms at Day 182 (prior to Dose 3) and p = 0.99 for comparison of BK-SE36 arms at Day 210 (4 weeks post Dose 3).