Table 3. Summary of subjects 2 to 5 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 | By age group | ||
---|---|---|---|
Children (2 to 5 y) n = 27 |
Children (2 to 3 y) n = 18 |
Children (4 to 5 y) n = 9 |
|
Any reaction, n (%) | 20 (74) | 13 (72) | 7 (78) |
Any local reactions, n (%) Reactions, n (%) Tenderness, any Tenderness, severe |
16 (59) 11 (41) 0 |
10 (56) 7 (39) 0 |
6 (67) 4 (44) 0 |
Erythema, any Erythema > 100 mm |
7 (26) 0 |
5 (28) 0 |
2 (22) 0 |
Induration, any Induration > 100 mm |
5 (19) 0 |
3 (17) 0 |
2 (22) 0 |
Any systemic reactions, n (%) Reactions, n (%) Change in eating habits Sleepiness Irritability Vomiting Diarrhea Rash, any Rash, urticarial Body temperature (≥38 °C – Fever) Other reactions, n (%) Body temperature ≥ 40 °C Use of analgesics/antipyretics |
13 (48) 1 (4) 9 (33) 7 (26) 1 (4) 3 (11) 1 (4) 0 1 (4) 0 2 (7) |
7 (39) 1 (6) 5 (28) 3 (17) 0 2 (11) 1 (6) 0 1 (6) 0 0 |
6 (67) 0 4 (44) 4 (44) 1 (11) 1 (11) 0 0 0 0 2 (22) |