Status: Planned First registered on: 16/08/2021
Last updated on: 26/08/2021
1. Study identification
EU PAS Register NumberEUPAS42467
Official titleRapid Safety Assessment of SARS-CoV-2 vaccines in EU Member States using electronic health care datasources
Study title acronymCVM Covid19-Vaccine-Monitor-EHR
Study typeObservational study
Brief description of the studyReadiness The readiness phase will include the following objectives: • To provide an overview of the methods for identification of COVID-19 vaccine exposure in the data sources • To monitor the number of individuals exposed to any COVID-19 vaccine and to compare this to COVID-19 vaccine exposure data • To quantitatively evaluate different algorithms to identify adverse events by provenance in electronic health care data • To conduct time-to-onset analyses for the AESI with respect to time since vaccination • To assess the association between and the vaccines of interest and negative control events using the SCRI to estimate systematic bias (unmeasured confounding) • To test the impact of different comparators in the cohort design, using the negative control outcomes • To generate information for testing of methodological questions around misclassification of events/exposure Rapid assessment studies Primary objective The primary objective for this rapid assessment study is to assess the potential association between the occurrence of specific AESIs and vaccination with COVID-19 vaccines within disease-specific risk periods in individuals exposed to the COVID-19 vaccines compared to other COVID-19 vaccine exposed individuals or compared to a control window within the same individual. Secondary objectives The secondary objectives for the rapid assessments studies are: • To assess the potential association between the occurrence of specific AESIs and vaccination with COVID-19 vaccines in the following subgroups o immunocompromised persons o persons with the presence of co-morbidities elevating the risk of serious COVID-19 o persons with a history of diagnosed COVID-19 disease o pregnant women o age groups o patients with a prior history (ever) of that event more than a year before. Study design: A retrospective, multi-database, self-controlled risk interval or cohort study
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
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 belongsUMCU
Department/Research groupDatascience & Biostatistics
Organisation/affiliationUniversity Medical Center Utrecht
Website/Homepagewww.umcutrecht.nl
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

EU PE&PV
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?14

ARS
FISABIO, Spain
University Oslo, Norway
Countries in which this study is being conducted
International study

Belgium
Italy
Netherlands
Norway
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed06/04/2021
Start date of data collection31/08/2021
Start date of data analysis
Date of interim report, if expected
Date of final study report06/04/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherEMA100
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)31657831983 
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)31657831983 
Alternative phone number 
Fax number (incl. country code) 
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