Table 3.
Non-inferiority of SII-NVX-CoV2373 to NVX-SARS-CoV-2 Vaccine in terms of Anti-S IgG Antibodies at 14 days after second dose– Immunogenicity analysis Population – Phase 3.
| Multiple Imputationa Results Using Rubin's Methodb |
SII-NVX-CoV2373 (N = 340) | NVX-CoV2373 (N = 110) |
|---|---|---|
| Estimated Mean | ||
| GMEUc | 139937.78 | 153200.54 |
| 95% Confidence Interval | (116839.75, 167602.05) | (124050.99, 189199.68) |
| Estimated Ratio | ||
| GMEU Ratioc | 0.91 | |
| 95% Confidence Interval | (0.79, 1.06) | |
a
Multiple Imputation model with classification variables vaccine, age group, sex, comorbidity status and continuous covariates log baseline titer used to impute 50 values for each missing value.
b
Rubin's method in PROC MIANALYZE used to pool estimates and SE across the 50 multiply imputed datasets.
c
Pooled ANCOVA results, LS Mean and it's 95% CI values by treatment were used to generate the GMEU and 95% CI and the differences in LS Means and corresponding 95% CI limits were used to obtain GMEU Ratio and 95% CI using back transforming to the original scale.