Primary outcomes
infections
INFECTIONS
Through month 36, a total of 75 incident-persistent infections were detected in the HPV 16/18 mITT cohort: 1 among the nonavalent vaccine group, 2 among participants assigned to the bivalent vaccine group, and 72 among those assigned to the control vaccine group (Table Incidence of persistent HPV and vaccine efficacyNC, 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. 