Study identification

PURI

https://redirect.ema.europa.eu/resource/45470

EU PAS number

EUPAS44273

Study ID

45470

Official title and acronym

Post-Authorization Active Surveillance Safety Study Using Secondary Data to Monitor Real-World Safety of Spikevax in Europe (COVID-19)

DARWIN EU® study

No

Study countries

Denmark
Italy
Norway
Spain
United Kingdom

Study description

The overarching research question of this study: Is the occurrence of each adverse event of special interest (AESI) among persons vaccinated with Spikevax in Europe higher than the occurrence of that AESI that would have been expected in the same population in the absence of Spikevax? Primary objective:  To assess whether vaccination with Spikevax (by dose number where feasible and for any dose) is associated with increased rates of the AESI compared with the expected rates overall and stratified by country, sex, and age group Secondary objective:  To assess whether vaccination with Spikevax is associated with increased rates of the AESI compared with the expected rates in subpopulations of interest: women of childbearing age, patients who are immunocompromised, patients previously diagnosed with COVID-19 infection, patients with unstable health conditions and comorbidities, and patients with autoimmune or inflammatory disorders

Study status

Ongoing
Research institution and networks

Institutions

Aarhus University Hospital
Julius Clinical Research
Netherlands
First published:
06/03/2024
Institution
Non-Pharmaceutical companyENCePP partner
University of Oslo Oslo, Norway, Julius Clinical Zeist, The Netherlands

Networks

Contact details

Henrik Toft Sørensen

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Moderna
Study protocol
Initial protocol

mRNA-1273_P904_EU_PASS_Protocol_1.2. 27Sep2021 redacted for ENCePP

English (2.2 MB - PDF)View document
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)