Study identification

PURI

https://redirect.ema.europa.eu/resource/48839

EU PAS number

EUPAS45362

Study ID

48839

Official title and acronym

An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using European Healthcare Data through VAC4EU (COVID-19)

DARWIN EU® study

No

Study countries

Italy
Netherlands
Norway
Spain
United Kingdom

Study description

Observational Study, Retrospective observational study using electronic health care databases of various types in Europe. This study has 2 chronologically consecutive aims: 1) to conduct a feasibility assessment aiming to inform the safety evaluation study and 2) to assess the risk of developing pre-specified and newly identified AESIs following administration of Ad26.COV2.S.

Study status

Ongoing
Research institution and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
Institution
Not-for-profit
ENCePP partner
FISABIO Valencia, Spain, Teamit Institute Barcelona, Spain, SIMG-HS Italy, University of Olso Norway

Networks

Contact details

Fariba Ahmadizar

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

Janssen
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)