Table 3.
Primary, secondary, and exploratory equivalence (Study 1) and non-inferiority (Study 2) assessments; per protocol analysis set.
| Assessment type (Criterion) | Comparison | GMC ratio (95% CI) | Equivalent: Y/N |
|---|---|---|---|
| Study 1: Primary (2/3 [0.67] <95% CI ratio <11/2 [1.5]) | |||
| Day 57 | Group 2 [Bern WVS] vs Group 3 [Leiden MVSa] | 0.9 (0.65–1.17) | N |
| Study 1: Secondary (2/3 [0.67]) <95% CI ratio <11/2 [1.5]) | |||
| Day 57 | Group 1 [Leiden WVS] vs Group 2 [Bern WVS] | 1.1 (0.81–1.47) | Y |
| Day 57 | Group 1 [Leiden WVS] vs Group 3 [Leiden MVSa] | 1.0 (0.71–1.29) | Y |
| Day 78 | Group 1 [Leiden WVS] vs Group 2 [Bern WVS] | 1.1 (0.83–1.38) | Y |
| Day 78 | Group 1 [Leiden WVS] vs Group 3 [Leiden MVSa] | 0.9 (0.73–1.21) | Y |
| Day 78 | Group 2 [Bern WVS] vs Group 3 [Leiden MVSa] | 0.9 (0.68–1.13) | Y |
| Study 2: Primary (2/3 [0.67] <95% CI ratio) | |||
| Day 78 | Group 2 [intermediate dose] vs Group 1 [full clinical dose] | 0.7 (0.56–0.83) | N |
| Day 78 | Group 3 [low dose] vs Group 1 [full clinical dose]b | 0.8 (0.63–0.94) | — |
| Study 2: Exploratory (1/2 [0.5] <95% CI ratio) | |||
| Day 78 | Group 2 [intermediate dose] vs Group 1 [full clinical dose] | 0.7 (0.56–0.83) | Y |
| Day 78 | Group 3 [low dose] vs Group 1 [full clinical dose] | 0.8 (0.63–0.94) | Y |
| Study 2: Exploratoryc (2/3 [0.67] <95% CI ratio) | |||
| Day 57 | Group 2 [intermediate dose] vs Group 1 [full clinical dose] | 0.8 (0.68–1.04) | Y |
| Day 57 | Group 3 [low dose] vs Group 1 [full clinical dose] | 0.6 (0.51–0.77) | N |
aSame Leiden MVS batch as used in phase 1/2 studies.
bHierarchical testing (i.e., to be tested only if non-inferiority is established for the primary comparison of Group 2 vs Group 1).
cPost-hoc exploratory analysis.
CI: confidence interval; GMC: geometric mean concentration; MVS: master virus seed; N: no; WVS: working virus seed; Y: yes.