Status: Ongoing First registered on: 26/01/2022
Last updated on: 05/09/2022
1. Study identification
EU PAS Register NumberEUPAS45362
Official titleAn Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using European Healthcare Data through VAC4EU (COVID-19)
Study title acronym
Study typeObservational study
Brief description of the studyObservational Study, Retrospective observational study using electronic health care databases of various types in Europe. This study has 2 chronologically consecutive aims: 1) to conduct a feasibility assessment aiming to inform the safety evaluation study and 2) to assess the risk of developing pre-specified and newly identified AESIs following administration of Ad26.COV2.S.
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 nameUniversity Medical Center Utrecht
Centre locationUtrecht, Netherlands
Details of (Primary) lead investigator
Title Professor
Last name Sturkenboom
First name Miriam
Is this study being carried out with the collaboration of a research network?
Yes

Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?8

ARS
FISABIO, Valencia, Spain
Teamit Institute, Barcelona, Spain
SIMG-HS, Italy
University of Olso, Norway
Countries in which this study is being conducted
International study

Italy
Netherlands
Norway
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed28/02/202221/04/2022
Start date of data collection21/05/202223/05/2022
Start date of data analysis
Date of interim report, if expected
Date of final study report22/10/2024
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesJanssen100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Sturkenboom
First name Miriam
Address line 1Heidelberglaan 100
Address line 2 
Address line 3 
CityUtrecht 
Postcode 
CountryNetherlands
Phone number (incl. country code)31887555555 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Professor 
Last name Sturkenboom 
First name Miriam 
Address line 1Heidelberglaan 100 
Address line 2 
Address line 3 
CityUtrecht 
Postcode 
CountryNetherlands 
Phone number (incl. country code)31887555555 
Alternative phone number 
Fax number (incl. country code) 
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