Table 5.
Incidence rate and relative risk of potential immune mediated disease preferred terms reported in multiple trial participants in AS03-adjuvanted vaccines and control groups and background rates reported in the literature
| Participants considered | Total N | N Rate per 100,000 person-years ( 95% CI) for adjuvanted vaccine recipients* | N Rate per 100,000 person-years (95% CI) for control recipients** | Relative Risk*** (95% CI) | Background rates reported in the literature |
|---|---|---|---|---|---|
| Facial paresis and/or VIIth nerve paralysis | |||||
| Controlled and uncontrolled trials | 7 | 6 55.6 (20.4; 121.0) |
1 20.1 (0.5; 112.3) |
Not calculated | 13.1 – 46.725–31 |
| Controlled trials | 5 | 4 45.2 (12.3; 115.8) |
1 20.1 (0.5, 112.3) |
2.3 (0.2; 118.1) |
|
| Polymyalgia rheumatica or temporal arteritis | |||||
| Controlled and uncontrolled trials | 7 | 6 55.6 (20.4; 121.0) |
1 20.1 (0.5; 112.3) |
Not calculated | 12.7 – 112.6 32–34 |
| Controlled trials | 6 | 5 56.5 (18.4; 131.9) |
1 20.1 (0.5; 112.3) |
2.6 (0.3; 131.4) |
|
| Psoriasis | |||||
| Controlled and uncontrolled trials | 4 | 3 27.8 (5.7; 81.2) |
1 20.1 (0.5; 112.3) |
Not calculated | 38.5 – 140.0 35,36 |
| Controlled trials | 3 | 2 22.6 (2.7; 81.7) |
1 20.1 (0.5; 112.3) |
0.7 (0.0; 39.3) |
|
| Autoimmune thyroiditis or Basedow's disease | |||||
| Controlled and uncontrolled trials | 3 | 3 33.9 (7.0; 99.1) |
0 0.0 (0.0; 74.3) |
Not calculated | 2.2 – 41.9 37–40 |
| Controlled trials | 3 | 3 33.9 (7.0; 99.1) |
0 0.0 (0.0; 74.3) |
Infinity (0.3; Infinity) |
|
| Celiac disease | |||||
| Controlled and uncontrolled trials | 3 | 2 22.6 (2.7; 81.6) |
1 20.1 (0.5; 112.3) |
Not calculated | 1.4 – 12.9 43,44 |
| Controlled trials | 3 | 2 22.6 (2.7; 81.6) |
1 20.1 (0.5; 112.3) |
1.5 (0.1; 91.6) |
|
| Multiple sclerosis | |||||
| Controlled and uncontrolled trials | 2 | 1 9.3 (0.2; 51.6) |
1 20.1 ( 0.5; 112.3) |
Not calculated | 4.6 – 25.0 25,30 41,42 |
| Controlled trials | 1 | 0 0 (0.0; 41.7) |
1 20.1 (0.5; 112.3) |
0.0 (0.0; 39.0) |
|
| Thrombocytopenia | |||||
| Controlled and uncontrolled trials | 3 | 3 33.9 (7.0; 99.1) |
0 0 (0.0; 74.3) |
Not calculated | 0.0 – 7.1 25,41,85 |
| Controlled trials | 3 | 3 33.9 (7.0; 99.1) |
0 0 (0.0; 74.3) |
Infinity (0.4; Infinity) |
|
| Radiculitis or radiculopathy | |||||
| Controlled and uncontrolled trials | 3 | 1 11.3 (0.3; 63.0) |
2 40.3 (4.9; 145.6) |
Not calculated | 83.2 45 |
| Controlled trials | 3 | 1 11.3 (0.3; 63.0) |
2 40.3 (4.9; 145.6) |
0.3 (0.0; 7.1) |
|
| Uveitis | |||||
| Controlled and uncontrolled trials | 2 | 1 11.3 (0.3; 63.0) |
1 20.1 (0.5; 112.3) |
Not calculated | 10.5 – 52.4 41,50 |
| Controlled trials | 2 | 1 11.3 (0.3; 63.0) |
1 20.1 (0.5; 112.3) |
0.6 (0.0; 53.5) |
|
| Ulcerative colitis | |||||
| Controlled and uncontrolled trials | 2 | 2 22.6 (2.7; 81.7) |
0 0.0 (0.0; 74.3) |
Not calculated | 0.3 – 17.0 46,47 |
| Controlled trials | 2 | 2 22.6 (2.7; 81.7) |
0 0.0 (0.0; 74.3) |
Infinity (0.1; Infinity) |
|
| Rheumatoid arthritis | |||||
| Controlled and uncontrolled trials | 2 | 1 11.3 (0.3, 63.0) |
1 20.1 (0.5; 112.3) |
Not calculated | 8.3 – 36.0 41,48,49 |
| Controlled trials | 2 | 1 11.3 (0.3; 63.0) |
1 20.1 (0.5; 112.3) |
0.6 (0.0; 52.2) |
*Total person-years = 10,797 for controlled and uncontrolled H5N1 and A(H1N1)pdm09 trials and 8,846 for controlled H5N1 and A(H1N1)pdm09 trials.
**Total person-years = 4,964.
***RR was computed for the controlled trials only.
N, number of participants; CI, confidence interval; Infinity explicit value cannot be defined due to the absence of cases in the control group.