Study identification

EU PAS number

EUPAS49836

Study ID

49837

Official title and acronym

An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using Health Insurance Databases in the United States

DARWIN EU® study

No

Study countries

United States

Study description

Retrospective observational study using health insurance claims in the United States to access the risk of developing pre-specified adverse events of special interest, following administration of Ad26.COV2.S.

Study status

Finalised
Research institutions and networks

Institutions

HealthCore
First published:
01/02/2024
Institution
Optum
Germany
First published:
07/02/2014
Institution Outdated Other ENCePP partner
RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
Institution Not-for-profit ENCePP partner
CVS Health (Aetna), Hartford, Connecticut, USA
Humana, Louisville, Kentucky, USA

Contact details

Nicolas Praet

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
Pharmaceutical company and other private sector 

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)