Table 2.

Incidence rate per 100,000 person-years and incidence rate ratios^* of co-primary endpoints.

		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
Co-primary endpoints
Neuroinflammatory/ophthalmic AD	Confirmed cases	0	0.00 (0.00–5.70)	1	1.54 (0.04–8.59)	—
	All cases	4	6.18 (1.68–15.83)	7	10.80 (4.34–22.24)	0.57 (0.17–1.96)
Other AD	Confirmed cases	38	58.73 (51.56–80.61)	27	41.64 (27.44–60.58)	1.41 (0.86–2.31)
	All cases	51	78.82 (58.69–103.63)	41	63.23 (45.38–85.78)	1.25 (0.83–1.88)
		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
Co-primary endpoints
Neuroinflammatory/ophthalmic AD	Confirmed cases	1	1.54 (0.04–8.59)	1	1.54 (0.04–8.59)	0.95 (0.06–15.18)
	All cases	3	4.63 (0.95–13.52)	2	3.08 (0.37–11.14)	1.73 (0.29–10.47)
Other AD	Confirmed cases	26	40.09 (26.19–58.74)	15	23.12 (12.94–38.14)	1.77 (0.94–3.35)
	All cases	28	43.17 (28.69–62.39)	19	29.29 (17.64–45.74)	1.52 (0.85–2.73)

Note. AD = autoimmune disease; 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)