Table 4.
Safety outcomes (SafAS)
| Participants experiencing at least one: | MenACYW-TT (N=230) |
MCV4-TT (N=232) |
MenC-TT (N=239) |
|||
|---|---|---|---|---|---|---|
| n/M | % (95% CI) | n/M | % (95% CI) | n/M | % (95% CI) | |
| Immediate unsolicited AE | 0/230 | 0 (0, 1.6) | 0/232 | 0 (0, 1.6) | 0/239 | 0 (0, 1.5) |
| Solicited reaction | 185/230 | 80.4 (74.7, 85.4) | 182/231 | 78.8 (72.9, 83.9) | 179/239 | 74.9 (68.9, 80.3) |
| Solicited injection site reaction | 136/230 | 59.1 (52.5, 65.5) | 127/231 | 55.0 (48.3, 61.5) | 129/239 | 54.0 (47.4, 60.4) |
| Solicited systemic reaction | 140/230 | 60.9 (54.2, 67.2) | 138/231 | 59.7 (53.1, 66.1) | 138/239 | 57.7 (51.2, 64.1) |
| Unsolicited AE | 124/230 | 53.9 (47.2, 60.5) | 112/232 | 48.3 (41.7, 54.9) | 129/239 | 54.0 (47.4, 60.4) |
| Unsolicited AR | 15/230 | 6.5 (3.7, 10.5) | 11/232 | 4.7 (2.4; 8.3) | 12/239 | 5.0 (2.6; 8.6) |
| AE leading to discontinuation | 0/230 | 0 (0, 1.6) | 0/232 | 0 (0, 1.6) | 0/239 | 0 (0, 1.5) |
| SAE, Day 0 to Day 30 | 1/230 | 0.4 (0, 2.4) | 1/232 | 0.4 (0, 2.4) | 2/239 | 0.8 (.1, 3.0) |
| AESI | 0/230 | 0 (0, 1.6) | 1/232 | 0.4 (0, 2.4) | 1/239 | 0.4 (0, 2.3) |
| Death | 0/230 | 0 (0, 1.6) | 0/232 | 0 (0, 1.6) | 0/239 | 0 (0, 1.5) |
AE, adverse event; AESI, adverse event of special interest; M, number of participants with available data; N, total population; n, number experiencing outcome; SAE, serious adverse event; SafAS, safety analysis set.