TABLE 3.
Local (injection site) reactions
| Reaction | Intensityd | No. (%) of subjects reporting the specified reaction
|
||
|---|---|---|---|---|
| Men B/C (n = 35) | MenB (n = 18) | Men C (n = 19) | ||
| Pain | 1st inj.—all | 35 (100) | 18 (100) | 18 (95) |
| 1st inj.—severe | 4 (11) | 0 | 0 | |
| 2nd inj.—all | 31 (100)b | 16 (100) | 17 (89)c | |
| 2nd inj.—severe | 3 (10) | 1 (6) | 0 | |
| 3rd inj.—all | 30 (100)b | 15 (100) | 14 (74)c | |
| 3rd inj.—severe | 1 (3) | 1 (7) | 0 | |
| Total any inj.—all | 35 (100) | 18 (100) | 19 (100) | |
| Total any inj.—severea | 7 (20) | 2 (11) | 0 | |
| Redness | 1st inj.—all | 13 (37) | 8 (44) | 1 (5) |
| 1st inj.—severe | 1 (3) | 0 | 0 | |
| 2nd inj.—all | 9 (29)b | 8 (50) | 1 (5)c | |
| 2nd inj.—severe | 0 | 0 | 0 | |
| 3rd inj.—all | 10 (33)b | 5 (33) | 0c | |
| 3rd inj.—severe | 2 (7) | 0 | 0 | |
| Total any inj.—all | 20 (57) | 11 (61) | 2 (11) | |
| Total any inj.—severea | 3 (9) | 0 | 0 | |
| Swelling | 1st inj.—all | 16 (46) | 7 (39) | 5 (26) |
| 1st inj.—severe | 3 (9) | 0 | 0 | |
| 2nd inj.—all | 18 (58)b | 4 (25) | 3 (16)c | |
| 2nd inj.—severe | 1 (3) | 1 (6) | 0 | |
| 3rd inj.—all | 14 (47)b | 6 (40) | 1 (5)c | |
| 3rd inj.—severe | 1 (3) | 0 | 0 | |
| Total any inj.—all | 23 (66) | 10 (56) | 6 (32) | |
| Total any inj.—severea | 4 (11) | 1 (6) | 0 | |
a
Most severe across all injections.
b
Subjects in the MenB/C group received MenBvac only at the 2nd and 3rd dose.
c
Subjects in the MenC group received placebo [Al(OH)3] at the 2nd and 3rd dose.
d
inj., injection; all, all intensity levels.