A Long-term Follow-up Registry-based Cohort Study of HPV Vaccine Efficacy Against Cervical Pre-cancerous Lesions and Cervical Cancers in a Cohort of Females Previously Enrolled From Finland in Study HPV-008, as Compared to a Non-intervention Population -Based Reference Cohort of Females From Finland
Observational Model: Cohort, Time Perspective: Prospective
Occurrence of intraepithelial neoplasia grade 3 or worse (CIN3+). including CIN3, cervical cancer (squamous cell carcinoma or adenocarcinoma).
To estimate the long-term vaccine efficacy by comparing the incidence rate of cervical cancers and pre-cancerous lesions (CIN3+) in Cohort A vs. Cohort C.
The time frame is up to 15 years (for the interim analyses: 4, 7 and 10 years). (Start and end of passive follow-up, Cohorts A and B: 01.01.2010 - 31.12. 2024; Cohorts C1 and C2: 01.10.2007/01.10.2008 - 30.09.2021/30.09.2023.)
Matti Lehtinen, M.D., Ph.D.
University of Tampere
Finland: Finnish Medicines Agency