Table 4.
Incidence rate per 100,000 person-years and incidence rate ratios* of individual autoimmune diseases with >10 cases in female cohorts.
| AS04-HPV-16/18 vaccine exposure (total PY = 64,705) |
Unexposed historical female cohort (total PY = 64,841) |
|||||
|---|---|---|---|---|---|---|
| Diseases | n | IR per 100,000 PY (95% CI) | n | IR per 100,000 PY (95% CI) | IRR* (95% CI) EXP/NNEXP | |
| Autoimmune thyroiditis | Confirmed cases | 15 | 23.18 (12.98;38.24) | 4 | 6.17 (1.68; 15.80) | 3.75 (1.25–11.31) |
| All cases | 26 | 40.18 (26.25;58.88) | 18 | 27.76 (16.45;43.87) | 1.45 (0.79–2.64) | |
| Crohn's disease | Confirmed cases | 6 | 9.27 (3.40;20.18) | 5 | 7.71 (2.50;18.00) | 1.21 (0.37–3.95) |
| All cases | 8 | 12.36 (5.34;24.26) | 5 | 7.71 (2.50;18.00) | 1.61 (0.53–4.91) | |
| Type 1 diabetes mellitus | Confirmed cases | 8 | 12.36 (5.34;24.36) | 16 | 24.68 (14.10;40.07) | 0.30 (0.11–0.83)** |
| All cases | 8 | 12.36 (5.34;24.36) | 16 | 24.68 (14.10;40.07) | 0.50 (0.21–1.17) | |
|
Unexposed concurrent male cohort (total PY = 64,859) |
Unexposed historical male cohort (total PY = 64,868) |
|||||
|
Diseases |
|
n |
IR per 100,000 PY (95% CI) |
n |
IR per 100,000 PY (95% CI) |
IRR*(95% CI) MALE/HIST |
| Autoimmune thyroiditis | Confirmed cases | 0 | 0.00 (0.00; 5.69) | 0 | 0.00 (0.00; 5.69) | — |
| All cases | 2 | 3.08 (0.37;11.14) | 3 | 4.63 (0.95;13.52) | 0.76 (0.13–4.60) | |
| Crohn's disease | Confirmed cases | 4 | 6.17 (1.68;15.79) | 1 | 1.54 (0.04;8.59) | 4.22 (0.47–38.02) |
| All cases | 4 | 6.17 (1.68;15.79) | 2 | 3.08 (0.37;11.14) | 2.06 (0.38–11.34) | |
| Type 1 diabetes mellitus | Confirmed cases | 20 | 30.84 (18.84;47.62) | 8 | 12.33 (5.32;24.30) | 2.46 (1.08–5.60) |
| All cases | 20 | 30.84 (18.84;47.62) | 8 | 12.33 (5.32;24.30) | 2.46 (1.08–5.60) | |
Note. CI = confidence interval; EXP = AS04-HPV-16/18 vaccine exposure; HIST = unexposed historical male cohort; IRR = incidence rate ratio; MALE = unexposed concurrent male cohort; n = number of subjects; NNEXP = unexposed historical female cohort; PY = person-years
*
Adjusted for age group (9–17 years, 18–25 years)
**
The IRR for confirmed type 1 diabetes in the female cohorts was adjusted for the male effect, because a significant difference in incidence rates was observed between the 2 male cohorts