Table 3.
Seroconversion rate difference two weeks post second vaccine dose – mITT set.
| Test Group (N = 214)‡ |
Comparator Group (N = 219)‡ |
Test – Comparator |
Adjusted† |
||||||
|---|---|---|---|---|---|---|---|---|---|
| All ages | Number of seroconverted (%) | 95% CI of seroconverted | Number of seroconverted (%) | 95% CI of seroconverted | Difference (%) | 95% CI of Difference | p-value§ | Difference (%) | 95% CI of Difference |
| O1 Inaba | 181 (84.6%) | (79.1, 88.8) | 191 (87.2%) | (82.1, 91.0) | −2.6 | (−9.3, 4.0) | 0.000 | −2.5 | (−8.7, 3.8) |
| O1 Ogawa | 192 (89.7%) | (84.9, 93.1) | 200 (91.3%) | (86.9, 94.4) | −1.6 | (−7.3, 4.0) | 0.000 | −2.6 | (−7.9, 2.7) |
| O139 | 121 (56.5%) | (49.8, 63.0) | 114 (52.1%) | (45.5, 58.6) | 4.5 | (−4.9, 13.7) | 0.013 | 4.5 | (−4.3, 13.4) |
| By age cohorts | |||||||||
| Test Group (N = 95)‡ |
Comparator Group (N = 98)‡ |
Test – Comparator |
Adjusted† |
||||||
| Adults cohort | # of seroconverted (%) | 95% CI of seroconverted | # of seroconverted (%) | 95% CI of seroconverted | Difference (%) | 95% CI of Difference | p-value§ | Difference (%) | 95% CI of Difference |
| O1 Inaba | 76 (80.0%) | (70.86, 86.81) | 81 (82.7%) | (74.0, 88.9) | −2.7 | (−13.7, 8.4) | 0.015 | −2.6 | (−13.3, 8.0) |
| O1 Ogawa | 83 (87.4%) | (79.21, 92.62) | 87 (88.8%) | (81.0, 93.6) | −1.4 | (−10.9, 8.0) | 0.003 | −3.5 | (−12.4, 5.3) |
| O139 | 49 (51.6%) | (41.67, 61.37) | 47 (48.0%) | (38.3, 57.7) | 3.6 | (−10.3, 17.4) | 0.055 | 3.9 | (−8.8, 16.5) |
| Test Group (N = 119)‡ | Comparator Group (N = 121) | Test – Comparator | Adjusted† | ||||||
| Children cohort | # of seroconverted (%) | 95% CI of seroconverted | # of seroconverted (%) | 95% CI of seroconverted | Difference (%) | 95% CI of Difference | p-value§ | Difference (%) | 95% CI of Difference |
| O1 Inaba | 105 (88.2%) | (81.2, 92.9) | 110 (90.9%) | (84.5, 94.9) | −2.7 | (−10.7, 5.3) | 0.002 | −2.4 | (−9.8, 5.0) |
| O1 Ogawa | 109 (91.6%) | (85.2, 95.4) | 113 (93.4%) | (87.5, 96.619) | −1.8 | (−8.9, 5.2) | 0.001 | −3.9 | (−11.4, 3.6) |
| O139 | 72 (60.5%) | (51.5, 68.8) | 67 (55.4%) | (46.5, 63.939) | 5.1 | (−7.3, 17.3) | 0.059 | 5.0 | (−6.8, 16.9) |
The 2 participants (1 adult and 1 child) in Test group and 1 adult in Comparator group who did not have immunogenicity endpoint at Visit 3 were excluded from the analysis.
The p-value has been derived using Equivalence test with margin [−15%, +15%]. The equivalence test was conducted by performing two separate tests at 2.5% significance level: (1) for lower bound, Difference <−15% versus Difference ≥−15%, and (2) for upper bound, Difference >+15% versus Difference ≤+15%. The overall p-value which is the higher of the two p-values of those tests was presented. If p-value <0.025, the two vaccine groups are equivalent.
Adjusted for study sites in the model and additionally age strata in all ages combined, and in children cohort when analyzed separately.