TABLE 3.
Adverse vaccine reactions occurring in more than one subject in either treatment group
| Reaction | No. (%) of subjects |
Pa | |
|---|---|---|---|
| BCG (n = 12) | VPM1002 (n = 36) | ||
| Scar | 11 (91.7) | 33 (91.7) | 1.0000 |
| Erythema | 11 (91.7) | 32 (88.9) | 1.0000 |
| Nodule | 8 (66.7) | 28 (77.8) | 0.4619 |
| Scab | 6 (50.0) | 16 (44.4) | 0.7514 |
| Injection site mass | 4 (33.3) | 10 (27.8) | 0.7260 |
| Abscessb | 5 (41.7) | 4 (11.1) | 0.0321* |
| Ulcer | 1 (8.3) | 5 (13.9) | 1.0000 |
| Discoloration | 1 (8.3) | 3 (8.3) | 1.0000 |
| Regional lymphadenopathy | 3 (25.0) | 9 (25.0) | 1.0000 |
a
P values were determined using the Fisher exact test. *, P < 0.05.
b
No subject required surgical intervention.