Status: Ongoing First registered on: 29/11/2021
Last updated on: 31/01/2022
1. Study identification
EU PAS Register NumberEUPAS44450
Official titleMonitoring safety of Spikevax in pregnancy: an observational study using routinely collected health data in five European countries (COVID-19)
Study title acronym
Study typeObservational study
Brief description of the studyThe 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?
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?6

IDIAPJGol
DSRU
Aarhus University Dept. of Clinical Epidemiology
ARS
University of Oslo, Norway
Julius Clinical, 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 signed26/03/2021
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 1Department 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 1Madrid, Spain 
Address line 2 
Address line 3 
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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