Table 3.
Safety overview (safety analysis set)
| JE-CV (n = 137) | SA14–14—2 (n = 137) | |||||
|---|---|---|---|---|---|---|
| Children experiencing at least one: | n | % | (95% CI) | n | % | (95% CI) |
| Immediate unsolicited AE | 0 | 0.0 | (0.0; 2.7) | 0 | 0.0 | (0.0; 2.7) |
| Solicited reaction | 87 | 63.5 | (54.9; 71.6) | 97 | 70.8 | (62.4; 78.3) |
| Solicited injection site reaction | 45 | 32.8 | (25.1; 41.4) | 56 | 40.9 | (32.6; 49.6) |
| Pain | 35 | 25.5 | (18.5; 33.7) | 38 | 27.7 | (20.4; 36.0) |
| Erythema | 23 | 16.8 | (11.0; 24.1) | 33 | 24.1 | (17.2; 32.1) |
| Swelling | 6 | 4.4 | (1.6; 9.3) | 10 | 7.3 | (3.6; 13.0) |
| Solicited systemic reaction | 72 | 52.6 | (43.9; 61.1) | 73 | 53.3 | (44.6; 61.9) |
| Appetite loss | 38 | 27.7 | (20.4; 36.0) | 40 | 29.2 | (21.7; 37.6) |
| Irritability | 31 | 22.6 | (15.9; 30.6) | 36 | 26.3 | (19.1; 34.5) |
| Crying abnormal | 27 | 19.7 | (13.4; 27.4) | 35 | 25.5 | (18.5; 33.7) |
| Fever | 33 | 24.6 | (17.6; 32.8) | 34 | 25.0 | (18.0; 33.1) |
| Drowsiness | 23 | 16.8 | (11.0; 24.1) | 33 | 24.1 | (17.2; 32.1) |
| Vomiting | 9 | 6.6 | (3.0; 12.1) | 14 | 10.2 | (5.7; 16.6) |
| Unsolicited AE | 95 | 69.3 | (60.9; 76.9) | 99 | 72.3 | (64.0; 79.6) |
| Unsolicited AR | 7 | 5.1 | (2.1; 10.2) | 8 | 5.8 | (2.6; 11.2) |
| AE leading to study discontinuation | 0 | 0.0 | (0.0; 2.7) | 0 | 0.0 | (0.0; 2.7) |
| SAE during the study | 17 | 12.4 | (7.4; 19.1) | 18 | 13.1 | (8.0; 20.0) |
Solicited injection site reactions (pain, erythema and swelling) include date within 7 d of vaccination; solicited systemic reactions (fever, vomiting, crying [abnormal], drowsiness, appetite lost and irritability) include data within 14 d of vaccination; N, total number of children; n, number of children; CI, confidence interval; AE, adverse event; AR, adverse reaction; SAE, serious adverse event.