Table 1.
Baseline characteristics of the study participants at enrollment within each vaccine arm.
| Study cohorts | Cohort 1: 25-60 months | Cohort 2: 12 –24 months | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Arm | BK-SE36 | Control (Synflorix) | Total | BK-SE36 | Control (Synflorix) | Total | |||
| Route | SC | IM | IM | SC | IM | IM | |||
| n | 18 | 18 | 18 | 54 | 18 | 18 | 18 | 54 | |
| Gender | Male | 7 (39%) | 7 (39%) | 6 (33%) | 20 (37%) | 8 (44%) | 6 (33%) | 8 (44%) | 22 (41%) |
| Female | 11 (61%) | 11 (61%) | 12 (67%) | 34 (63%) | 10 (56%) | 12 (67%) | 10 (56%) | 32 (59%) | |
| Age (months) | (mean ± SD) | 43.7 ± 11.3 | 46.1 ± 9.6 | 47.8 ± 9.0 | 45.9 ± 10 | 18.5 ± 3.7 | 18.2 ± 3.1 | 19.3 ± 3.0 | 18.7 ± 3.3 |
| Height (cms) | (mean ± SD) | 93 ± 7 | 96 ± 6 | 96 ± 7 | 95 ± 7 | 78 ± 4 | 77 ± 3 | 79 ± 4 | 78 ± 3 |
| Weight (kgs) | (mean ± SD) | 13.5 ± 1.8 | 14.8 ± 1.8 | 14.8 ± 2.2 | 14.4 ± 2.0 | 9.4 ± 1.0 | 9.0 ± 1.1 | 9.5 ± 1.4 | 9.3 ± 1.20 |
| Body mass index (BMI) | (mean ± SD) | 15.6 ± 1.1 | 16.0 ± 1.4 | 15.9 ± 1.4 | 15.8 ± 1.3 | 15.5 ± 1.6 | 15.0 ± 1.3 | 15.2 ± 1.2 | 15.2 ± 1.4 |
SC, subcutaneous route; IM, intramuscular route; n, no. of subjects.