TABLE 2.
Numbers and percentage of participants reporting solicited adverse events (AEs) within 1 to 7 days of vaccination and unsolicited AEs during the 30-day postvaccination perioda
| AE | No. (%) of participants with AEb |
||||
|---|---|---|---|---|---|
| MenABCWY (n = 100) | 4CMenB+MenACWY/S (n = 104) | 4CMenB+MenACWY/D (n = 100) | 4CMenB (n = 94) | MenACWY (n = 102) | |
| Solicited AEc | |||||
| Dose 1 | |||||
| Any | 93 (93.0) | 102 (98.1) | 97 (97.0) | 93 (98.9) | 76 (74.5) |
| Local | 90 (90.0) | 101 (97.1) | 97 (97.0) | 90 (95.7) | 59 (57.8) |
| Systemic | 69 (69.0) | 73 (70.2) | 66 (66.0) | 61 (64.9) | 60 (58.8) |
| Dose 2 | |||||
| Any | 90 (90.0) | 98 (94.2) | 96 (96.0) | 91 (96.8) | |
| Local | 89 (89.0) | 98 (94.2) | 96 (96.0) | 90 (95.7) | |
| Systemic | 71 (71.0) | 65 (62.5) | 69 (69.0) | 63 (67.0) | |
| At least 1 unsolicited AE | 23 (23.0) | 27 (26.0) | 26 (26.0) | 23 (24.5) | 15 (14.7) |
| Related to vaccination | 8 (8.0) | 11 (10.6) | 13 (13.0) | 11 (11.7) | 4 (3.9) |
| Leading to medically attended visit | 14 (14.0) | 17 (16.3) | 14 (14.0) | 13 (13.8) | 6 (5.9) |
Shown are the numbers and percentages of participants reporting solicited adverse events (AEs) within 1 to 7 days of vaccination and unsolicited AEs during the 30-day postvaccination period following one dose (MenACWY group) or one and two vaccine doses (all other groups). All participants were randomized.
/S, vaccines administered concomitantly in the same arm; /D, vaccines administered concomitantly in different arms; n, number of participants; no., number of participants in a specific category.
Solicited local AEs include erythema, swelling, induration, and pain, and solicited systemic AEs include arthralgia, fatigue, nausea, headache, myalgia, and fever.