TABLE 3.
Numbers and percentages of participants reporting solicited local and systemic adverse events (AEs) within 1 to 7 days of each vaccine dosea
| AE | Dose | Severityb | No. (%) of participants reporting AEc |
||||
|---|---|---|---|---|---|---|---|
| MenABCWY (n = 100) | 4CMenB+MenACWY/S (n = 104) | 4CMenB+MenACWY/D (n = 100) | 4CMenB (n = 94) | MenACWY (n = 102) | |||
| Local | |||||||
| Erythema | 1 | Any | 17 (17.0) | 19 (18.3) | 18 (18.0) | 9 (9.6) | 7 (6.9) |
| >100 mm | 3 (3.0) | 2 (1.9) | 1 (1.0) | 0 | 1 (1.0) | ||
| 2 | Any | 15 (15.0) | 18 (17.3) | 15 (15.0) | 10 (10.6) | ||
| >100 mm | 1 (1.0) | 1 (1.0) | 2 (2.0) | 0 | |||
| Swelling | 1 | Any | 20 (20.0) | 21 (20.2) | 16 (16.0) | 13 (13.8) | 10 (9.8) |
| >100 mm | 2 (2.0) | 1 (1.0) | 1 (1.0) | 0 | 0 | ||
| 2 | Any | 13 (13.0) | 14 (13.5) | 15 (15.0) | 12 (12.8) | ||
| >100 mm | 1 (1.0) | 1 (1.0) | 1 (1.0) | 0 | |||
| Induration | 1 | Any | 9 (9.0) | 15 (14.4) | 12 (12.0) | 6 (6.4) | 4 (3.9) |
| >100 mm | 1 (1.0) | 0 | 1 (1.0) | 0 | 0 | ||
| 2 | Any | 6 (6.0) | 11 (10.6) | 12 (12.0) | 12 (12.8) | ||
| >100 mm | 0 | 1 (1.0) | 1 (1.0) | 0 | |||
| Pain | 1 | Any | 89 (89.0) | 100 (96.2) | 95 (95.0) | 88 (93.6) | 52 (51.0) |
| Severe | 15 (15.0) | 22 (21.2) | 16 (16.0) | 12 (12.8) | 3 (2.9) | ||
| 2 | Any | 87 (87.0) | 97 (93.3) | 95 (95.0) | 87 (92.6) | ||
| Severe | 19 (19.0) | 22 (21.2) | 26 (26.0) | 15 (16.0) | |||
| Systemic | |||||||
| Arthralgia | 1 | Any | 20 (20.4) | 15 (15.0) | 9 (9.4) | 9 (10.5) | 18 (18.4) |
| Severe | 2 (2.0) | 2 (2.0) | 1 (1.0) | 0 | 0 | ||
| 2 | Any | 22 (22.4) | 19 (18.4) | 12 (12.2) | 17 (18.5) | ||
| Severe | 5 (5.1) | 1 (1.0) | 1 (1.0) | 1 (1.1) | |||
| Fatigue | 1 | Any | 56 (56.6) | 61 (59.8) | 55 (55.0) | 46 (50.0) | 50 (50.0) |
| Severe | 9 (9.1) | 8 (7.8) | 2 (2.0) | 7 (7.6) | 7 (7.0) | ||
| 2 | Any | 58 (58.0) | 61 (58.7) | 62 (62.0) | 56 (59.6) | ||
| Severe | 10 (10.0) | 7 (6.7) | 9 (9.0) | 11 (11.7) | |||
| Nausea | 1 | Any | 16 (16.5) | 23 (22.8) | 14 (14.4) | 13 (15.3) | 14 (14.1) |
| Severe | 1 (1.0) | 3 (3.0) | 1 (1.0) | 0 | 0 | ||
| 2 | Any | 16 (16.3) | 13 (12.7) | 15 (15.3) | 17 (18.3) | ||
| Severe | 2 (2.0) | 3 (2.9) | 1 (1.0) | 2 (2.2) | |||
| Headache | 1 | Any | 40 (40.8) | 46 (45.1) | 38 (38.8) | 36 (39.1) | 36 (36.4) |
| Severe | 4 (4.1) | 4 (3.9) | 3 (3.1) | 4 (4.3) | 4 (4.0) | ||
| 2 | Any | 52 (53.1) | 36 (34.6) | 37 (37.0) | 39 (41.9) | ||
| Severe | 6 (6.1) | 5 (4.8) | 3 (3.0) | 2 (2.2) | |||
| Myalgia | 1 | Any | 34 (34.7) | 29 (28.7) | 27 (27.8) | 21 (24.1) | 28 (28.3) |
| Severe | 6 (6.1) | 4 (4.0) | 0 | 2 (2.3) | 4 (4.0) | ||
| 2 | Any | 41 (41.8) | 38 (36.9) | 35 (35.4) | 38 (40.4) | ||
| Severe | 7 (7.1) | 4 (3.9) | 2 (2.0) | 3 (3.2) | |||
| Fever (≥38°C) | 1 | Yes | 6 (6.0) | 5 (4.9) | 5 (5.0) | 1 (1.1) | 3 (3.0) |
| 2 | Yes | 6 (6.0) | 3 (2.9) | 3 (3.0) | 1 (1.1) | ||
a
All participants were randomized.
b
Severe pain, arthralgia, fatigue, headache, and myalgia were defined as preventing normal daily activities; severe nausea was defined as leading to minimal or no oral intake; severe fever was defined as a body temperature of ≥40°C (no reports).
c
/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.