217743 - An observational, retrospective database post-authorisation safety study (PASS) to assess trends and changes over time in incidence of anal cancer and feasibility for a case-control study in European countries that introduced Cervarix in their National Immunisation Programmes (NIP) (EPI-HPV-099 VS EUR DB)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48885
• EU PAS number:
  EUPAS42373
• Study ID:
  48885
• Official title and acronym:
  217743 - An observational, retrospective database post-authorisation safety study (PASS) to assess trends and changes over time in incidence of anal cancer and feasibility for a case-control study in European countries that introduced Cervarix in their National Immunisation Programmes (NIP) (EPI-HPV-099 VS EUR DB)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  Netherlands

  Norway

  United Kingdom
• Study description:
  The aim of this study is to assess trends and changes over time in incidence of anal cancer using data reported to the national cancer registries in Finland, the Netherlands, England, Denmark, and Norway and to carry out an assessment of feasibility to conduct a case-control study in any of these 5 European countries aiming to determine the impact and effectiveness of GSK’s HPV vaccine against anal cancer in females and males.
• Study status:
  Finalised

Research institutions and networks

Institutions

Finnish Cancer Registry

Finland

Finnish Cancer Registry

Finland

Public Health Evaluation and Projection/Vaccine Safety Evaluation, National Institute for Health and Welfare

Finland

The Netherlands Cancer Registry Netherlands, National Cancer Registration and Analysis Service UK, The Danish Cancer Registry Denmark, The Cancer Registry of Norway Norway, Dutch vaccination registry (Præventis) Netherlands, Child Health Information Systems England, Danish vaccination registry Denmark, Norwegian vaccination registry Norway

Study timelines

Date when funding contract was signed

Actual: 14/07/2021

Study start date

Actual: 12/08/2021

Date of final study report

Actual: 27/03/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

Redacted EPI-HPV-099 Protocol Amendment 2 Anonymized 27 Sep 2022

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)