Table 2.
Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) two weeks post second vaccine dose – mITT set.
| Test Group (N = 214)* |
Comparator Group (N = 219)* |
Test/Comparator |
Adjusted‡ Test/Comparator |
||||||
|---|---|---|---|---|---|---|---|---|---|
| All Ages | GMT | 95% CI | GMT | 95% CI | GMR | 95% CI | p-value† | GMR | 95% CI |
| O1 Inaba | 1128.10 | (862.49, 1475.52) | 1376.65 | (1108.91, 1709.04) | 0.82 | (0.58, 1.16) | 0.002 | 0.89 | (0.66, 1.20) |
| O1 Ogawa | 1457.06 | (1174.97, 1806.87) | 1552.60 | (1255.50, 1920.00) | 0.94 | (0.69, 1.27) | 0.000 | 0.99 | (0.76, 1.29) |
| O139 | 14.78 | (11.23, 19.46) | 12.42 | (9.43, 16.35) | 1.19 | (0.81, 1.75) | 0.004 | 1.25 | (0.89, 1.75) |
| By Age cohorts | |||||||||
| Test Group (N = 95)* |
Comparator Group (N = 98)* |
Test/Comparator |
Adjusted‡ Test/Comparator |
||||||
| Adults cohort | GMT | 95% CI of GMT | GMT | 95% CI of GMT | GMR | 95% CI of GMR | p-value† | GMR | 95% CI of GMR |
| O1 Inaba | 1593.21 | (1140.61, 2225.39) | 1354.52 | (983.88, 1864.77) | 1.18 | (0.74, 1.86) | 0.012 | 1.20 | (0.80, 1.79) |
| O1 Ogawa | 1688.97 | (1258.17, 2267.28) | 1383.56 | (1054.79, 1814.82) | 1.22 | (0.82, 1.82) | 0.008 | 1.10 | (0.79, 1.53) |
| O139 | 11.22 | (7.40, 17.02) | 9.42 | (6.37, 13.91) | 1.19 | (0.68, 2.10) | 0.037 | 1.28 | (0.79, 2.06) |
| Test Group (N = 119)* |
Comparator Group (N = 121) |
Test/Comparator |
Adjusted‡ Test/Comparator |
||||||
| Children cohort | GMT | 95% CI of GMT | GMT | 95% CI of GMT | GMR | 95% CI of GMR | p-value† | GMR | 95% CI of GMR |
| O1 Inaba | 856.37 | (574.19, 1277.24) | 1394.85 | (1035.73, 1878.49) | 0.61 | (0.37, 1.01) | 0.208 | 0.69 | (0.46, 1.05) |
| O1 Ogawa | 1295.00 | (950.28, 1764.77) | 1704.52 | (1240.28, 2342.53) | 0.76 | (0.49, 1.18) | 0.032 | 0.87 | (0.60, 1.27) |
| O139 | 18.42 | (12.77, 26.56) | 15.54 | (10.57, 22.84) | 1.19 | (0.70, 2.01) | 0.026 | 1.22 | (0.76, 1.95) |
The 2 participants (1 adult and 1 child) in Test group and 1 adult in Comparator group who did not have immunogenicity endpoint two weeks post second dose were excluded from the analysis.
The p-value has been derived using Equivalence test with margin [0.5, 2.0]. The equivalence test was conducted by performing two separate tests at 2.5% significance level: (1) for lower bound, GMR < 0.5 versus GMR ≥ 0.5, and (2) for upper bound, GMR > 2.0 versus GMR ≤ 2.0. The overall p-value which is the larger of the two p-values of those tests was presented. If p-value <0.025, the two vaccine groups are equivalent.
Adjusted for baseline titers and study sites in the model and additionally age strata in children cohort.