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

22/03/2024
02/03/2026
EU PAS number:
EUPAS1000000080
Study
Finalised
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Study identification

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

Norway
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 licensed HPV vaccines in Europe.
Main objectives:
- To assess the effectiveness of HPV vaccination in prevention of invasive cervical cancer stratified by licensed 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

Institutions

Networks

Contact details

Daniel Prieto Alhambra

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable