Table 4.
Summary of Adverse Events
| Adverse Event | 34 Patients, Aged 0 to <2 Years, No. (%) | 54 Patients, Aged 2 to <5 Years, No. (%) | 88 Patients Total, No. (%) |
|---|---|---|---|
| None | 20 (59) | 21 (39) | 41 (47) |
| Any adverse eventa | 14 (41) | 33 (61) | 47 (53) |
| Local reactionb | 9 (26) | 27 (50) | 36 (41) |
| Upper respiratory tract infection | 1 (3) | 14 (26) | 15 (17) |
| Pruritus | 1 (3) | 2 (4.7) | 3 (3) |
| Bronchitis | 0 (0) | 1 (2) | 1 (1) |
| Pyrexia | 0 (0) | 1 (2) | 1 (1) |
| Sinusitis | 0 (0) | 1 (2) | 1 (1) |
| Otitis media | 0 (0) | 1 (2) | 1 (1) |
| Irritability | 3 (9) | 0 (0) | 3 (3) |
aMultiple adverse events occurred in some patients
bBased on 16 MedDRA preferred terms