Status: Ongoing First registered on: 25/11/2021
Last updated on: 31/01/2022
1. Study identification
EU PAS Register NumberEUPAS44273
Official titlePost-Authorization Active Surveillance Safety Study Using Secondary Data to Monitor Real-World Safety of Spikevax in Europe (COVID-19)
Study title acronym
Study typeObservational study
Brief description of the studyThe 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
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 belongsAarhus University Dept. of Clinical Epidemiology
Department/Research groupAarhus University, Dept of Clinical Epidemiology
Organisation/affiliationAarhus University / Aarhus University Hospital
Website/Homepagewww.kea.au.dk
Details of (Primary) lead investigator
Title Professor
Last name Sørensen
First name Henrik Toft
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?5

IDIAPJGol
DSRU
Aarhus University Dept. of Clinical Epidemiology
ARS
University of Oslo, Oslo, Norway
Julius Clinical, Zeist, The Netherlands
Countries in which this study is being conducted
International study

Denmark
Italy
Norway
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed26/05/2021
Start date of data collection31/12/202131/12/2021
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesModerna100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Ehrenstein
First name Vera
Address line 1Dept of Clinical Epidemiology
Address line 2Olof Palmes Alle 43-45 
Address line 3 
CityAarhus N 
Postcode8200 
CountryDenmark
Phone number (incl. country code)4550122006 
Alternative phone number 
Fax number (incl. country code) 
Email address ve@clin.au.dk
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 328010 
CityMadrid 
Postcode 
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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