Table 8.
Power for Testing that an Immunological Biomarker has Some Surrogate Endpoint Value: H0: VE(s) = VE versus H1: VE(s) varies in s [Complete Sampling]*.
| Analysis | Counts | Infections | Analysis | Counts | Infections | |
|---|---|---|---|---|---|---|
| Diagnosed Through 24 Month | Diagnosed Through 36 Months | |||||
| True VE(s) | 1Vac Arm |
2Vac Arms |
3Vac Arms |
1Vac Arm |
2Vac Arms |
3Vac Arms |
| BIP + CRPV Design | ||||||
|
VE(s) = 0.50 (Null) |
0.04 | 0.05 | 0.04 | 0.05 | 0.05 | 0.04 |
|
VE(s) = mod. increase |
0.35 | 0.45 | 0.53 | 0.58 | 0.73 | 0.79 |
|
VE(s) = large increase |
0.81 | 0.91 | 0.95 | 0.9 | 0.97 | 0.99 |
| BIP Design | ||||||
|
VE(s) = 0.50 (Null) |
0.05 | 0.05 | 0.06 | 0.05 | 0.05 | 0.04 |
|
VE(s) = mod. increase |
0.41 | 0.49 | 0.52 | 0.61 | 0.71 | 0.76 |
|
VE(s) = large increase |
0.83 | 0.91 | 0.94 | 0.91 | 0.97 | 0.99 |
| CRPV Design | ||||||
|
VE(s) = 0.50 (Null) |
0.05 | 0.04 | 0.06 | 0.05 | 0.05 | 0.05 |
|
VE(s) = mod. increase |
0.13 | 0.14 | 0.14 | 0.18 | 0.24 | 0.25 |
|
VE(s) = large increase |
0.22 | 0.28 | 0.33 | 0.36 | 0.44 | 0.47 |
*
For the BIP + CRPV and BIP designs the BIP has linear correlation 0.8 with the immunological biomarker S. For the BIP + CRPV and CRPV designs, all placebo recipients uninfected at closeout are vaccinated and have S measured.