Table 4. Summary of subjects ≥6 y of age experiencing local and/or systemic solicited reactions within a week of a single dose of MenACWY-CRM197, overall and by age group.
|
Overall (≥ 6 y) n = 170 |
Children (6 to 10 y) n = 38 |
By Age group Adolescents (11 to 17 y) n = 66 |
Adults (≥18 y) n = 66 |
|
|---|---|---|---|---|
| Any reaction, n (%) | 108 (64) | 22 (58) | 42 (64) | 44 (67) |
|
Local reactions, any, n (%) Reactions, n (%) Injection site pain, any Injection site pain, severe |
90 (53) 82 (48) 5 (3) |
18 (47) 16 (42) 2 (5) |
33 (50) 33 (50) 0 |
39 (59) 33 (50) 3 (5) |
|
Erythema, any Erythema, >100 mm |
30 (18) 3 (2) |
7 (18) 1 (3) |
12 (18) 1 (2) |
11 (17) 1 (2) |
|
Induration, any Induration, >100 mm |
23 (14) 3 (2) |
4 (11) 1 (3) |
11 (17) 1 (2) |
8 (12) 1 (2) |
|
Systemic reactions, any, n (%) Reactions, n (%) Chills, any |
68 (40) 16 (9) |
12 (32) 3 (8) |
30 (45) 5 (8) |
26 (39) 8 (12) |
| Chills, severe | 1 (1) | 1 (3) | 0 | 0 |
| Nausea, any | 13 (8) | 1 (3) | 7 (11) | 5 (8) |
| Nausea, severe | 2 (1) | 0 | 1 (2) | 1 (2) |
|
Malaise, any Malaise, severe |
34 (20) 6 (4) |
6 (16) 1 (3) |
15 (23) 3 (5) |
13 (20) 2 (3) |
|
Myalgia, any Myalgia, severe Arthralgia, any Arthralgia, severe Headache, any Headache, severe Rash, any Rash, urticarial Body temperature (≥38 °C- Fever) 38 °C-38.4 °C |
33 (19) 5 (3) 15 (9) 0 43 (25) 2 (1) 4 (2) 1 (1) 5 (3) 1 (1) |
5 (13) 2 (5) 1 (3) 0 7 (18) 1 (3) 1 (3) 0 2 (5) 1 (3) |
19 (29) 0 7 (11) 0 18 (27) 1 (2) 0 0 2 (3) 0 |
9 (14) 3 (5) 7 (11) 0 18 (27) 0 3 (5) 1 (2) 1 (2) 0 |
| 38.5 °C-38.9 °C | 3 (2) | 1 (3) | 1 (2) | 1 (2) |
|
Other reactions, n (%) 39 °C-39.4 °C 39.5 °C-39.9 °C |
0 1 (1) |
0 0 |
0 1 (2) |
0 0 |
|
≥40 °C Use of analgesics/antipyretics |
0 19 (11) |
0 7 (18) |
0 6 (9) |
0 6 (9) |