Table 5. Summary of adverse events before and after the second injection.
| N = 107 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Before 2nd injection | After 2nd injection | |||||||
| Number of subjects (%) | 95% CI† [lower, upper] | No. of events | Number of subjects (%) | 95% CI† [lower, upper] | No. of events | |||
| AE–injection site reaction | 8 | (7.48) | [3.28, 14.20] | [10] | 1 | (0.93) | [0.02, 5.10] | [1] |
| AE–other than injection site reaction | 5 | (4.67) | [1.53, 10.57] | [5] | 1 | (0.93) | [0.02, 5.10] | [2] |
| ADR | 7 | (6.54) | [2.67, 13.02] | [9] | 0 | (0.00) | [0.00, 3.39] | [0] |
| SAE | 0 | (0.00) | [0.00, 3.39] | [0] | 1 | (0.93) | [0.02, 5.10] | [1] |
| Serious ADR | 0 | (0.00) | [0.00, 3.39] | [0] | 0 | (0.00) | [0.00, 3.39] | [0] |
| Unexpected AE | 1 | (0.93) | [0.02, 5.10] | [1] | 1 | (0.93) | [0.02, 5.10] | [2] |
| Unexpected ADR | 0 | (0.00) | [0.00, 3.39] | [0] | 0 | (0.00) | [0.00, 3.39] | [0] |
AE, adverse event; ADR, adverse drug reaction; SAE, serious adverse event
† 95% CI calculated using the Clopper-Pearson method