Post-Marketing surveillance for HPV infection related serious disease in a cohort of Chinese women who received GARDASIL® and GARDASIL®9

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Register-based, observational surveillance activity

Population studied

• Short description of the study population:
  The study focused on cervical disease in Ningbo, specifically targeting female residents aged 16-45 years who received at least one dose of G4 or G9 HPV vaccine. The vaccinated cohort included eligible women who received the vaccine and have medical care information available on the Ningbo Regional Health Information Platform (NRHIP). ; Inclusion criteria:;  Female residents registered in the NRHIP;;  Health data available in the NRHIP;;  Received at least 1 dose of G4 or G9 during the study period (including those with a mixed regimen of G4 and G9);;  20 to 45 years old at initiation of G4 vaccination, or 16 to 26 years old at initiation of G9 vaccination. ; Exclusion criteria: ;  Women who received HPV vaccination other than G4 or G9; ; The unvaccinated cohort included eligible women who received no HPV vaccine and are matched based on factors like age, area of residence, and cervical HPV/cytology testing services. ; Inclusion criteria:;  Female residents registered in the NRHIP;;  Health data available in the NRHIP;; Exclusion criteria:;  Women who received HPV vaccination.; ; The study also women from the general population aged 45 years or more to better understand the occurrence of cervical disease reported to the NRHIP.; Inclusion criteria: ;  Female residents registered in the NRHIP;;  Health data available in the NRHIP.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Estimated number of subjects:
  50000

Study design details

• Main study objective:
  The primary objective is to monitor the occurrence of high-grade cervical intraepithelial neoplasia in a cohort of Chinese women who were vaccinated with GARDASIL® or GARDASIL®9 in Ningbo. The secondary objective is to monitor the occurrence of high-grade cervical intraepithelial neoplasia in a cohort of Chinese women without HPV vaccination, who are matched to the vaccinated women.
• Outcomes:
  High-grade cervical intraepithelial neoplasia
• Data analysis plan:
  The number of high-grade cervical intraepithelial neoplasia cases in the vaccinated cohort will be tabulated and presented overall and by calendar year and age. The occurrence of high-grade cervical intraepithelial neoplasia in the matched unvaccinated cohort and general population of women will also be summarized overall, and by calendar year and age. Rates of high-grade cervical intraepithelial neoplasia occurrence in vaccinated and matched unvaccinated cohorts will be reported and compared, if methodologically feasible. Consistent with principles of Good Pharmacoepidemiology Practice (GPP), we will assess the availability, quality, completeness, comparability, and limitations of the data for each cohort. The decision to calculate and report rates and rate comparisons will be based on the results of this data assessment and guided by application of GPP principles for observational studies.

Documents

Study results

V503-056-CSR- HPV PMC G9 effectiveness study report_final redaction

V503-056_Combined G4 and G9 Report with Cover Letter_final redaction