DARWIN EU® Effectiveness of Human Papillomavirus Vaccines (HPV) to prevent cervical cancer

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000080
• EU PAS number:
  EUPAS1000000080
• Study ID:
  1000000080
• Official title and acronym:
  DARWIN EU® Effectiveness of Human Papillomavirus Vaccines (HPV) to prevent cervical cancer
• DARWIN EU® study:
  Yes
• Study countries:
  Germany

  Spain

  United Kingdom
• Study description:
  Research question: What is the effectiveness of HPV vaccination in prevention of severe disease outcomes in women, including invasive cervical cancer and CIN2+ for the different licensed HPV vaccines in Europe. ; ; More specifically, the study objectives are: ; Main objectives: ; - To assess the effectiveness of HPV vaccination in prevention of invasive cervical cancer stratified by licenced vaccine brand ; - To assess the effectiveness of HPV vaccination in prevention of CIN2+, stratified by licenced vaccine brand ; - To assess the effectiveness of HPV vaccination in prevention of, conization, stratified by licenced vaccine brand ; ; Secondary objectives:; - To assess the effectiveness of HPV vaccination overall for the three outcomes (i.e. invasive cervical cancer, CIN2+ and conization) ; - To assess the effectiveness of HPV vaccination in prevention of invasive cervical cancer, CIN2+ and conization in subgroups defined by number of doses, within each brand. ; Results in both main and secondary analyses will be further stratified by age group.
• Study status:
  Finalised

Research institutions and networks

Networks

Data Analysis and Real World Interrogation Network (DARWIN EU®)

Belgium

Croatia

Denmark

Estonia

Finland

France

Germany

Hungary

Netherlands

Norway

Portugal

Spain

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 10/02/2023

Actual: 10/02/2023

Study start date

Planned: 10/02/2023

Actual: 10/02/2023

Date of final study report

Planned: 15/05/2024

Actual: 19/11/2024

Sources of funding

EMA

Study protocol

Initial protocol

DARWIN EU_D2.2.3 Protocol P2-C3-004_HPV_Final_v3.6 Public.pdf

Updated protocol

DARWIN EU_D2.2.3 Protocol P2-C3-004_HPV_Final_v3.6 Public.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable