Table 7. Clinical adverse experience summary (entire study duration).
| Vaccine (N=1908) n (%) | Placebo (N=1902) n (%) | |
|---|---|---|
| Subjects in analysis population | 1908 | 1902 |
| Subjects with follow-up | 1890 | 1888 |
| Number (%) of subjects | ||
| With one or more adverse experiences | 1645 (87.0) | 1535 (81.3) |
| Injection-site adverse experiences | 1450 (76.7) | 1213 (64.2) |
| Systemic adverse experiences | 1121 (59.3) | 1135 (60.1) |
| With vaccine-related adverse experiences | 1565 (82.8) | 1391 (73.7) |
| Injection-site adverse experiences | 1449 (76.7) | 1213 (64.2) |
| Systemic adverse experiences | 746 (39.5) | 697 (36.9) |
| With serious adverse experiences | 14 (0.7) | 16 (0.8) |
| With serious vaccine-related adverse experiences | 0 (0.0) | 0 (0.0) |
| Discontinued due to an adverse experience | 7 (0.4) | 2 (0.1) |
| discontinued due to a vaccine-related adverse experiencea | 5 (0.3) | 2 (0.1) |
| Discontinued due to a serious adverse experience | 2 (0.1) | 0 (0.0) |
| Discontinued due to a serious vaccine-related adverse experience | 0 (0.0) | 0 (0.0) |
| Who diedb | 7 (0.4) | 1 (0.1) |
N=number of subjects receiving at least one dose of vaccine or placebo with non-missing safety data; n=number of subjects contributing to the analysis.
Reasons for discontinuation due to a vaccine-related adverse experience in the vaccine group included hypersensitivity, urticaria, mouth ulceration, injection-site swelling, and facial oedema. Reasons for discontinuation due to a vaccine-related adverse experience in the placebo group included fatigue and overdose.
Reasons for death in the vaccine group included cardiac arrest secondary to breast cancer metastasis, cardiac arrest secondary to cerebrovascular accident, acute liver disease secondary to nasopharyngeal cancer, breast cancer, tuberculosis, pulmonary embolism, and pericarditis. Reasons for death in the placebo group included pulmonary embolism.