Table 2 Incidence of persistent HPV and vaccine efficacy

a
	HPV 16/18
	Nonavalent HPV		Bivalent HPV		Control		Nonvalent versus control		Bivalent versus control
	Events/ participants	Incidence of persistent HPV 16/18 per 100 woman-years (95% CI)	Events/ participants	Incidence of persistent HPV 16/18 per 100 woman-years (95% CI)	Events/ participants	Incidence of persistent HPV 16/18 per 100 woman-years (95% CI)	VE (95% CI)	P value	VE (95% CI)	P value
mITT Primary	1/496	0.08 (0–0.44)	2/489	0.16 (0.02–0.58)	72/473	6.70 (5.24–8.44)	98.8% (91.3–99.8%)	<0.0001	97.5% (90.0–99.4%)	<0.0001
mITT sensitivity	1/569	0.07 (0–0.39)	3/561	0.21 (0.04–0.62)	84/543	6.87 (5.48–8.51)	99.0% (92.5–99.9%)	<0.0001	96.8% (90.0–99.0%)	<0.0001
Extended sensitivity	0/429	0 (0–0.38)	0/404	0 (0–0.40)	44/380	5.52 (4.01–7.42)	100.0%* (NC)	<0.0001	100.0%* (NC)	<0.0001

b
	HPV 16/18/31/33/45/52/58
	Nonavalent HPV		Control		Nonvalent versus control
	Events/ participants	Incidence of persistent HPV 16/18/31/33/45/52/58 per 100 woman-years (95% CI)	Events/ participants	Incidence of persistent HPV 16/18/31/33/45/52/58 per 100 woman-years (95% CI)	VE (95% CI)	P value
mITT primary	5/325	0.61 (0.20–1.42)	84/290	13.8 (11.0–17.0)	95.5% (89.0–98.2%)	<0.0001
mITT sensitivity	8/437	0.74 (0.32–1.45)	116/392	14.4 (11.9–17.2)	94.8% (89.3–97.4%)	<0.0001
Extended sensitivity	1/264	0.17 (0–0.92)	50/210	12.1 (8.97–15.9)	98.6% (90.0–99.8%)	<0.0001

NC, not calculated. *VE computed as 100 × (1 − crude incidence rate ratio).
Incidence of persistent HPV by randomized vaccine group in the mITT primary, mITT sensitivity cohorts. For the HPV types specified, the mITT primary cohort includes participants who were HPV DNA and antibody negative at enrollment and DNA negative at month 3; the mITT sensitivity cohort includes participants who were HPV DNA negative at enrollment and month 3; and the extended-sensitivity cohort includes participants who were HPV DNA and antibody negative at enrollment, and DNA negative and months 3 and 6. Woman-years of follow-up time is computed from the month 3 swab collection date for the mITT primary and sensitivity cohorts, and from the month 6 swab collection date in the extended-sensitivity cohort. No multiplicity adjustments were performed. a, Incidence of persistent HPV 16/18 and VE. For the extended-sensitivity cohort comparisons, VE is reported as 100 × (1 − crude incidence rate ratio) due to 0 events in the nonavalent and bivalent HPV vaccine arms. Two-sided log-rank P values are computed for each comparison using the log-rank test. b, Incidence of persistent HPV 16/18/31/33/45/52/58 and VE. Two-sided log-rank P values are computed for each comparison using the log-rank test.

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