Study identification

PURI

https://redirect.ema.europa.eu/resource/45467

EU PAS number

EUPAS44450

Study ID

45467

Official title and acronym

Monitoring safety of Spikevax in pregnancy: an observational study using routinely collected health data in five European countries (COVID-19)

DARWIN EU® study

No

Study countries

Denmark
Italy
Norway
Spain
United Kingdom

Study description

The overarching research question is: is there a greater risk or prevalence of pregnancy complications, adverse pregnancy outcomes, or adverse neonatal outcomes following pregnancies exposed to Spikevax compared with pregnancies unexposed to Spikevax?

Study status

Ongoing
Research institution and networks

Institutions

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

Networks

Contact details

Henrik Toft Sørensen

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:

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-P905_EU_PASS_Pregnancy_Protocol_1.2 27Sep2021 redacted for ENCePP

English (2.03 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)