Status: Ongoing First registered on: 23/05/2023
Last updated on: 23/05/2023
1. Study identification
EU PAS Register NumberEUPAS105009
Official titleClinical course, outcomes and risk factors of myocarditis and pericarditis following administration of Moderna vaccines targeting SARS-CoV-2.
Study title acronym
Study typeObservational study
Brief description of the studyThe overarching goal of this study is to describe the clinical course, outcomes and risk factors for myocarditis and pericarditis associated with Moderna vaccination targeting SARS-CoV-2. We will investigate the clinical course in terms of morbidity and to identify the relevant prognostic factors using the study objectives
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsJulius Clinical Research
Department/Research group
Organisation/affiliationJulius Clinical Research
Website/Homepagehttps://www.juliusclinical.com/
Details of (Primary) lead investigator
Title Mr
Last name David
First name Ong
Is this study being carried out with the collaboration of a research network?
Yes

VAC4EU
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?6

IDIAPJGol
DSRU
Aarhus University Dept. of Clinical Epidemiology
Julius Clinical Research
FISABIO, Spain
University of Oslo, Norway
Countries in which this study is being conducted
International study

Denmark
Netherlands
Norway
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed23/03/202223/03/2022
Start date of data collection31/03/202331/03/2023
Start date of data analysis
Date of interim report, if expected
Date of final study report30/06/2025
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesModerna Tx100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Ong
First name David
Address line 1Broederplein 41
Address line 2 
Address line 3 
CityZeist 
Postcode3703CD 
CountryNetherlands
Phone number (incl. country code)31306569900 
Alternative phone number 
Fax number (incl. country code) 
Email address david.ong@juliusclinical.com
Public Enquiries
Title Ms 
Last name Esposito 
First name Daina 
Address line 1Moderna Biotech Spain, S.L. 
Address line 2Calle Monte Esquinza 30 
Address line 3 
CityMadrid 
Postcode28010 
CountrySpain 
Phone number (incl. country code)16174609338 
Alternative phone number 
Fax number (incl. country code) 
Email address Daina.Esposito@modernatx.com 
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