Table 2.
Safety overview during the 6–month follow-up.
| Adverse events | SCB-2019 | Placebo | ||
|---|---|---|---|---|
|
N = 15,070 |
N = 15,067 |
|||
| ns (ne) | % (95 % CI) | ns (ne) | % (95 % CI) | |
| Any unsolicited adverse events | 2497 (4132) | 16.6 (16.0–17.2) | 2597 (4419) | 17.2 (16.6–17.8) |
| Related to vaccination | 712 (1057) | 4.7 (4.4–5.1) | 480 (6 4 5) | 3.2 (2.9–3.5) |
| Severe | 73 (93) | 0.5 (0.4–0.6) | 93 (1 4 4) | 0.6 (0.5–0.8) |
| Any medically-attended adverse events | 1071 (1697) | 7.1 (6.7–7.5) | 1211 (1910) | 8.0 (7.6–8.5) |
| Any serious adverse events | 90 (1 1 4) | 0.6 (0.5–0.7) | 114 (1 7 6) | 0.8 (0.6–0.9) |
| Related to vaccination | 4 (4) | 0.0 (0.0–0.1) | 2 (4) | 0.0 (0.0–0.0) |
| Any adverse events of special interest | 323 (5 0 9) | 2.1 (1.9–2.4) | 496 (7 9 1) | 3.3 (3.0–3.6) |
| Related to vaccination | 12 (12) | 0.1 (0.0–0.1) | 13 (14) | 0.1 (0.0–0.1) |
| Any adverse events leading to early study termination | 9 (10) | 0.1 (0.0–0.1) | 23 (29) | 0.2 (0.1–0.2) |
| Death | 9 (9) | 0.1 (0.0–0.1) | 23 (29) | 0.2 (0.1–0.2) |
Abbreviations: CI, confidence interval.
N is the number of participants in the study arm used as denominator for percentage calculation; ne is the number of events; ns is the number of participants reporting the adverse event (AE).
For a participant reporting greater than 1 AE for a given symptom within 7 days post-vaccination, the most severe AE was included in the calculation of percentage.
A related AE was an AE that was considered to be probably or possibly caused by the study vaccination.