Table 6. Efficacy against HPV6/11/16/18-related persistent infection and disease in seropositive and PCR-negative subjects.

	qHPV vaccine (N=1910)				Placebo (N=1907)				Observed
End point	N	Cases	PYR	Rate	N	Cases	PYR	Rate	efficacy (%)	95% CI
HPV 6/11/16/18-related persistent infection, CIN, or EGL	506	5	1882.3	0.3	513	15	1868.0	0.8	66.9	(4.3, 90.6)
Persistent infection	496	5	1793.9	0.3	505	15	1788.7	0.8	66.8	(3.8, 90.5)
CIN (any grade) or EGL	506	0	1895.4	0.0	513	0	1901.2	0.0	NA	NA
By HPV type and age group
HPV 6/11/16/18-related persistent infection (all ages)	496	5	1793.9	0.3	505	15	1788.7	0.8	66.8	(3.8, 90.5)
24–year-olds	258	3	909.9	0.3	248	4	880.6	0.5	27.4	(−329.0, 89.4)
35–45 year-olds	238	2	884.0	0.2	257	11	908.2	1.2	81.3	(14.4, 98.0)
HPV 6/11-related persistent infection (all ages)	307	2	1128.2	0.2	297	4	1066.0	0.4	52.8	(−229.7, 95.7)
24–34 year-olds	154	1	550.6	0.2	143	1	520.9	0.2	5.4	(−7325.9, 98.8)
35–45 year-olds	153	1	577.6	0.2	154	3	545.2	0.6	68.5	(−291.8, 99.4)
HPV 16/18-related persistent infection (all ages)	284	3	1020.9	0.3	312	11	1112.9	1.0	70.3	(−12.5, 94.7)
24–34 year-olds	145	2	509.8	0.4	154	3	550.2	0.5	28.1	(−528.1, 94.0)
35–45 year-olds	139	1	511.1	0.2	158	8	562.8	1.4	86.2	(−2.7, 99.7)

Abbreviations: CI=confidence interval; CIN=cervical intraepithelial neoplasia; EGL=external genital lesion; NA=not applicable; PYR=person years at risk; qHPV=quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine; rate=incidence rate per 100 person years at risk.

N=Number of subjects randomised to the respective vaccination group who received at least 1 injection and were seropositive and DNA negative for the relevant vaccine HPV type at enrolment..

n=Number of subjects who have at least one follow-up visit after Day 1.