TABLE 5.
Incidence of local and general solicited symptoms over the three-dose vaccination coursea
| Symptom | Typeb | MenB 0-2-4m group (n = 481)
|
MenB 0-1-6m group (n = 476)
|
Control 0-1-6m group (n = 469)
|
P valuec for difference in incidence between MenB and control 0-1-6m groups | |||
|---|---|---|---|---|---|---|---|---|
| % | 95% CI | % | 95% CI | % | 95% CI | |||
| Pain | Any | 85.0 | 81.5-88.1 | 84. | 80.4-87.2 | 42.9 | 38.3-47.5 | <0.001 |
| Grade 3 | 11.0 | 8.4-14.2 | 10.3 | 7.7-13.4 | 0.9 | 0.2-2.2 | <0.001 | |
| Redness | Any | 26.8 | 22.9-31.0 | 30.0 | 26.0-34.4 | 8.3 | 6.0-11.2 | <0.001 |
| >50 mm | 1.5 | 0.6-3.0 | 1.7 | 0.7-3.3 | 0.0 | 0.0-0.8 | <0.001 | |
| Swelling | Any | 22.5 | 18.8-26.4 | 27.9 | 24.0-32.2 | 6.2 | 4.2-8.8 | <0.001 |
| >50 mm | 2.1 | 1.0-3.8 | 2.7 | 1.5-4.6 | 0.4 | 0.1-1.5 | 0.007 | |
| Fatigue | Any | 28.5 | 24.5-32.7 | 30.3 | 26.2-34.6 | 25.4 | 21.5-29.6 | 0.096 |
| Grade 3 | 1.7 | 0.7-3.3 | 2.1 | 1.0-3.8 | 1.3 | 0.5-2.8 | 0.451 | |
| Gastrointestinal symptoms | Any | 14.3 | 11.3-17.8 | 13.2 | 10.3-16.6 | 10.4 | 7.8-13.6 | 0.192 |
| Grade 3 | 1.2 | 0.5-2.7 | 1.9 | 0.9-3.6 | 2.3 | 1.2-4.2 | 0.658 | |
| Headache | Any | 28.3 | 24.3-32.5 | 35.9 | 31.6-40.4 | 25.2 | 21.3-29.3 | <0.001 |
| Grade 3 | 2.5 | 1.3-4.3 | 3.4 | 1.9-5.4 | 2.1 | 1.0-3.9 | 0.321 | |
| Rash | Any | 0.2 | 0.0-1.2 | 0.2 | 0.0-1.2 | 0.6 | 0.1-1.9 | 0.368 |
| Grade 3 | 0.0 | 0.0-0.8 | 0.0 | 0.0-0.8 | 0.0 | 0.0-0.8 | ||
| Fever (axillary route) | ≥37.5°C | 5.0 | 3.2-7.3 | 5.0 | 3.3-7.4 | 4.3 | 2.6-6.5 | 0.644 |
| >39.5°C | 0.0 | 0.0-0.8 | 0.0 | 0.0-0.8 | 0.0 | 0.0-0.8 | ||
a
n, number of injected doses. %, percentage of doses followed by specified symptom.
b
Symptoms were graded 1 to 3 in intensity, with grade 3 symptoms defined as those preventing normal activity. At the time of analysis, injection site redness or swelling of >50 mm in diameter and fever of >39.5°C were graded 3.
c
Two-sided Fisher's exact test (assuming independence of doses within subject).