Table 1.
Study population.
| SCB-2019 | Placebo | Total | |
|---|---|---|---|
| n (%) | n (%) | n (%) | |
| Enrolled set (Screening, ≥12 years) | – | – | 31,483 |
| Screen Failure | – | – | 1105 |
| No ICF signature | – | – | 40 |
| Randomized (≥12 years) | 15,176 | 15,162 | 30,338 |
| Did not receive any dose | 24 | 15 | 39 |
| Safety set (All exposed adults) | 15,070 (99.5) | 15,067 (99.5) | 30,137 (99.5) |
| Received only one dose | 1059 (7.0) | 1206 (8.0) | 2265 (7.5) |
| Treatment discontinuation | 1018 (6.8) | 1183 (7.9) | 2201 (7.3) |
| Other | 292 (1.9) | 390 (2.6) | 682 (2.3) |
| Adverse event | 274 (1.8) | 298 (2.0) | 572 (1.9) |
| Withdrawal by subject | 185 (1.2) | 206 (1.4) | 391 (1.3) |
| Lost to follow up | 194 (1.3) | 189 (1.3) | 383 (1.3) |
| Protocol deviation | 34 (0.2) | 47 (0.3) | 81 (0.3) |
| Pregnancy | 21 (0.1) | 26 (0.2) | 47 (0.2) |
| Physician decision | 18 (0.1) | 25 (0.2) | 43 (0.1) |
| Death | 0 | 2 (0.0) | 2 (0.0) |
| Received two doses | 14,011 (93.0) | 13,861 (92.0) | 27,872 (92.5) |
| Early discontinued from study | 988 (6.6) | 1161 (7.7) | 2149 (7.1) |
| Withdrawal by subject | 419 (2.8) | 547 (3.6) | 966 (3.2) |
| Lost to follow up | 307 (2.0) | 327 (2.2) | 634 (2.1) |
| Other | 220 (1.5) | 224 (1.5) | 444 (1.5) |
| Physician decision | 27 (0.2) | 28 (0.2) | 55 (0.2) |
| Death | 8 (0.1) | 22 (0.1) | 30 (0.1) |
| Protocol deviation | 6 (0.0) | 8 (0.1) | 14 (0.0) |
| Pregnancy | 1 (0.0) | 4 (0.0) | 5 (0.0) |
| Adverse event | 0 | 1 (0.0) | 1 (0.0) |
| Per-Protocol set (Efficacy)a | 6336 (41.8) | 6216 (41.0) | 12,552 (41.4) |
n is the number of participants in the study arm.
a
Per-Protocol Efficacy set includes participants who were seronegative for SARS-CoV-2 S protein at baseline and correctly received the full vaccination regimen and had no major protocol deviations up to 14 days after the second dose that could affect the vaccine efficacy. About half of the study participants were seropositive for SARS-Cov-2 S protein at baseline and were excluded from the Per-Protocol set.