TABLE 4.
Summary Safety Outcomes (Safety Analysis Set)
| MenACYW-TT | MenACWY-CRM | |||
|---|---|---|---|---|
| (n = 498) | (n = 494) | |||
| n/M | % (95% CI) | n/M | % (95% CI) | |
| AEs within 30 min after vaccine injection | ||||
| Immediate unsolicited AE | 0/498 | 0.0 (0.0-0.7) | 0/494 | 0.0 (0.0-0.7) |
| Immediate unsolicited AR | 0/498 | 0.0 (0.0-0.7) | 0/494 | 0.0 (0.0-0.7) |
| AEs within 30 d after vaccine injection | ||||
| Solicited reaction | 270/487 | 55.4 (50.9-59.9) | 296/486 | 60.9 (56.4-65.3) |
| Solicited injection site reaction | 228/487 | 46.8 (42.3-51.4) | 262/486 | 53.9 (49.4-58.4) |
| Pain | 188/487 | 38.6 (34.3-43.1) | 206/486 | 42.4 (37.9-46.9) |
| Erythema | 110/487 | 22.6 (18.9-26.6) | 153/485 | 31.5 (27.4-35.9) |
| Swelling | 67/484 | 13.8 (10.9-17.2) | 104/483 | 21.5 (17.9-25.5) |
| Solicited systemic reaction | 168/487 | 34.5 (30.3-38.9) | 180/486 | 37.0 (32.7-41.5) |
| Fever | 9/485 | 1.9 (0.9-3.5) | 13/479 | 2.7 (1.5-4.6) |
| Headache | 61/487 | 12.5 (9.7-15.8) | 56/486 | 11.5 (8.8-14.7) |
| Malaise | 103/487 | 21.1 (17.6-25.0) | 99/486 | 20.4 (16.9-24.2) |
| Myalgia | 98/487 | 20.1 (16.7-24.0) | 112/486 | 23.0 (19.4-27.1) |
| Unsolicited AE | 121/498 | 24.3 (20.6-28.3) | 145/494 | 29.4 (25.4-33.6) |
| Unsolicited AR | 10/498 | 2.0 (1.0-3.7) | 17/494 | 3.4 (2.0-5.5) |
| Related SAE | 0/498 | 0.0 (0.0-0.7) | 0/494 | 0.0 (0.0-0.7) |
| AEs during the study | ||||
| SAE | 0/498 | 0.0 (0.0-0.7) | 0/494 | 0.0 (0.0-0.7) |
| MAAEs between visits 1 and 2 | 65/498 | 13.1 (10.2-16.3) | 76/494 | 15.4 (12.3-18.9) |
| MAAE between visit 2 to 6-month follow-up | 155/498 | 31.1 (27.1-35.4) | 136/494 | 27.5 (23.6-31.7) |
AEs, adverse events; AR, adverse reaction; CI, confidence interval; M, number of participants with available data for the endpoint; MAAE, medically-attended AE; n, number of participants experiencing the endpoint. SAE, serious AE.