Table 4.
Local injection site reactions
| Dose‐level 1 | Dose‐level 2 | Dose‐level 3A | Dose‐level 3B | Dose‐level 4 | Dose‐level 5 | All dose‐levels, n (%) | |
|---|---|---|---|---|---|---|---|
| Reactionsa | 3 | 6 | 6 | 9 | 3 | 1 | 28 (44) |
| Primer | 1 | 1 | 3 | 3 | 2 | 0 | 10 (40) |
| First booster | 1 | 2 | 3 | 3 | 0 | 1 | 10 (50) |
| Second booster | 1 | 3 | 0 | 3 | 1 | 0 | 8 (42) |
| Typeb | |||||||
| Abscess | 0 | 0 | 0 | 0 | 0 | 0 | 0 (0) |
| Cellulitis | 0 | 0 | 0 | 0 | 0 | 0 | 0 (0) |
| Nodule | 0 | 0 | 1 | 0 | 0 | 0 | 1 (4) |
| Induration | 0 | 4 | 0 | 2 | 0 | 0 | 6 (21) |
| Swelling | 2 | 4 | 1 | 5 | 0 | 0 | 12 (43) |
| Pain | 2 | 0 | 3 | 7 | 1 | 1 | 14 (50) |
| Erythema | 1 | 1 | 0 | 0 | 1 | 0 | 3 (11) |
| Warmth | 1 | 4 | 4 | 6 | 2 | 0 | 17 (61) |
a
Number of local injection site reactions observed in 64 vaccine administrations in 26 patients.
b
Specification of local reaction type (multiple reaction types possible per reaction).