Table 1.
Baseline characteristics of the study population.
| Demographic Characteristics | Test Group | Comparator Group | Total | p-value | |
|---|---|---|---|---|---|
| Adults cohort | N = 99 | N = 99 | N = 198 | ||
| Gender | Male (%) | 47 (47.5) | 42 (42.4) | 89 (45) | 0.475 |
| Female (%) | 52 (52.5) | 57 (57.6) | 109 (55) | ||
| Age (years) | Mean (SD) | 28.3 (5.9) | 28.3 (6.1) | 28.3 (6) | 0.976 |
| Median (min, max) | 29 (18, 40) | 29 (18, 39) | 29 (18, 40) | ||
| Children cohort | N = 122 | N = 122 | N = 244 | ||
| Gender | Male (%) | 67 (54.9) | 64 (52.5) | 131 (53.7) | 0.700 |
| Female (%) | 55 (45.1) | 58 (47.5) | 113 (46.3) | ||
| Age (years) | Mean (SD) | 8.1 (4.7) | 8.8 (4.9) | 8.4 (4.8) | 0.290 |
| Median (min, max) | 8 (1, 17) | 9 (1, 17) | 9 (1, 17) | ||
| Baseline vibriocidal titers | Test Group | Comparator Group | p-value | |
| All Ages | N = 216 | N = 220 | ||
| O1 Inaba | GMT (95% CI) | 24.01 (16.58, 34.79) | 31.78 (22.62, 44.65) | 0.27 |
| O1 Ogawa | GMT (95% CI) | 27.22 (18.89, 39.22) | 32.39 (22.73, 46.14) | 0.50 |
| O139 | GMT (95% CI) | 1.73 (1.52, 1.97) | 1.85 (1.59, 2.15) | 0.50 |
| Adults cohort | N = 96 | N = 99 | ||
| O1 Inaba | GMT (95% CI) | 52.63 (30.82, 89.87) | 57.57 (35.23, 94.07) | 0.81 |
| O1 Ogawa | GMT (95% CI) | 73.36 (43.97, 122.41) | 50.05 (30.39, 82.41) | 0.29 |
| O139 | GMT (95% CI) | 1.69 (1.40, 2.04) | 1.90 (1.53, 2.36) | 0.42 |
| Children cohort | N = 96 | N = 99 | ||
| O1 Inaba | GMT (95% CI) | 12.82 (7.86, 20.91) | 19.55 (12.37, 30.89) | 0.21 |
| O1 Ogawa | GMT (95% CI) | 12.31 (7.66, 19.78) | 22.69 (13.83, 37.21) | 0.08 |
| O139 | GMT (95% CI) | 1.76 (1.47, 2.12) | 1.81 (1.47, 2.24) | 0.84 |
| Baseline vibriocidal titers | Test Group | Comparator Group | p-value | |
| All Ages | N = 216 | N = 220 | ||
| O1 Inaba > 80 | n (%) | 78 (17.9) | 88 (20.2) | 0.40 |
| O1 Ogawa > 80 | n (%) | 91 (20.9) | 84 (19.3) | 0.40 |
| O139 > 80 | n (%) | 2 (0.5) | 7 (1.6) | 0.18 |
| Adults cohort | N = 96 | N = 99 | ||
| O1 Inaba > 80 | n (%) | 44 (22.6) | 52 (26.7) | 0.35 |
| O1 Ogawa > 80 | n (%) | 54 (27.7) | 47 (24.1) | 0.22 |
| O139 > 80 | n (%) | 0 (0) | 1 (0.5) | 1.00 |
| Children cohort | N = 120 | N = 121 | ||
| O1 Inaba > 80 | n (%) | 34 (14.1) | 36 (14.9) | 0.81 |
| O1 Ogawa > 80 | n (%) | 37 (15.4) | 37 (15.4) | 0.97 |
| O139 > 80 | n (%) | 2 (0.8) | 6 (2.5) | 0.28 |
| All Ages | N = 216 | N = 220 | ||
| O1 Inaba > 160 | n (%) | 58 (13.3) | 56 (12.8) | 0.74 |
| O1 Ogawa > 160 | n (%) | 60 (13.8) | 62 (14.2) | 0.93 |
| O139 > 160 | n (%) | 1 (0.2) | 2 (0.5) | 1.00 |
| Adults cohort | N = 96 | N = 99 | ||
| O1 Inaba > 160 | n (%) | 32 (16.4) | 31 (15.9) | 0.76 |
| O1 Ogawa > 160 | n (%) | 37 (19.0) | 35 (17.9) | 0.65 |
| O139 > 160 | n (%) | 0 (0) | 0 (0) | NA |
| Children cohort | N = 120 | N = 121 | ||
| O1 Inaba > 160 | n (%) | 26 (10.8) | 25 (10.4) | 0.85 |
| O1 Ogawa > 160 | n (%) | 23 (9.5) | 27 (11.2) | 0.55 |
| O139 > 160 | n (%) | 1 (0.4) | 2 (0.8) | 1.00 |