Table 2.
Summary of Local Reactions
| Characteristic | Cohort 1 | Cohort 2 | Cohort 2 |
|---|---|---|---|
| Single Dose | Initial Dose | Week 12 Dose | |
| Total No. of children | 10 | 11 | 10 |
| Total No. of injection sites | 10 | 16 | 16 |
| Average volume/injection site, mL (min, max) | 0.8 (0.8, 0.8) | 0.6 (0.4, 0.8) | 0.6 (0.3, 1.0) |
| Children with specified reaction, No. (%) | |||
| Any local reactiona | 6 (60) | 9 (82) | 2 (20) |
| Edema | 1 (10) | 5 (45) | … |
| Erythema/redness | 4 (40) | 6 (55) | 1 (10) |
| Induration | 2 (20) | … | 2 (20) |
| Bruising | 1 (10) | … | … |
| Grade average (min, max) | |||
| Any local reactiona | 1.0 (1, 1) | 1.0 (1, 1) | 2.0 (2, 2) |
| Edema | 1.0 (1, 1) | 1.0 (1, 1) | … |
| Erythema/redness | 1.0 (1, 1) | 1.0 (1, 1) | 2.0 (2, 2) |
| Induration | 1.0 (1, 1) | 1.0 (1, 1) | 1.5 (1, 2) |
| Bruising | 1.0 (1, 1) | … | … |
| Size average, cm (min, max) | |||
| Edema | 1.5 (1.5, 1.5) | 1.2 (1.0, 1.3) | … |
| Erythema/redness | 1.9 (1.5, 2.1) | 1.5 (1.0, 2.0) | 3.3 (3.3, 3.3) |
| Induration | 0.6 (0.1, 1.0) | … | 2.8 (2.1, 3.5) |
| Resolved by 1 h, No. (%) | |||
| Any local reactionb | 3 (60) | 8 (89) | 0 (0) |
| Edema | 1 (100) | 5 (100) | … |
| Erythema/redness | 4 (100) | 5 (83) | 1 (100) |
| Induration | 0 (0) | … | 0 (0) |
| Resolved by 4 h, No. (%) | |||
| Any local reactionb | 3 (60) | 8 (89) | … |
| Edema | 1 (100) | 5 (100) | … |
| Erythema/redness | 4 (100) | 5 (83) | … |
| Induration | 0 (0) | … | … |
| Resolved by 24 h, No. (%) | |||
| Any local reactionb | 5 (100) | 9 (100) | 2 (100) |
| Edema | 1 (100) | 5 (100) | … |
| Erythema/redness | 4 (100) | 6 (100) | … |
| Induration | 2 (100) | … | 2 (100) |
aThe values given for grade are the largest grade of any of the reactions reported (edema, erythema, induration, bruising) within that child, whichever group is specified.
bThe values given for percentage resolved by 1, 4, and 24 hours are the longest duration among edema, erythema, and induration (ie, these calculations exclude bruising, which is expected to be prolonged).