Status: Ongoing First registered on: 18/03/2021
Last updated on: 26/08/2021
1. Study identification
EU PAS Register NumberEUPAS39798
Official titleCohort Event Monitoring of safety of COVID-19 vaccines (Early-) Covid-Vaccine-Monitor
Study title acronymCovid-Vaccine-Monitor ECVM CVM
Study typeObservational study
Brief description of the studyPrimary aim: to generate incidence rates of patient-reported ADRs of COVID-19 vaccine brand in near real-time. Secondary aim: to describe differences in ADRs incidence rates between different vaccine batches used across the participating countries. In different countries, on the national level, data will be prospectively collected in near real-time, directly from a cohort of vaccine recipients. The common core data from different countries will be pooled and analysed at the European level. Vaccine recipients will be asked to fill in questionnaires at baseline, 1, 3, 5 and 8 weeks and 3 and 6 months after vaccination (from the first dose). The exact timing of the sending of the third questionnaire will depend on the vaccination interval between two doses. Safety data will be directly reported by vaccine recipients in their local language using the Lareb Intensive Monitoring (LIM) web app, which has been built specifically for patient-reported outcomes. Reported data from European countries using this LIM app can be stored in a dedicated central database. Data can also be collected nationally with non-LIM intensive monitoring tools/apps and countries can store and code data locally and share at regular intervals. ADR incidence rates within the vaccinated cohort will be reported cumulatively every month, overall and for the different vaccine brands, gender, age group, and countries. The protocol has been developed by the EU PE&PV research network as a deliverable of the framework contract No EMA/2018/28/PE with the European Medicines Agency.
Was this study requested by a regulator?Yes:
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 belongsNetherlands Pharmacovigilance Centre Lareb
Department/Research group
Organisation/affiliationNetherlands Pharmacovigilance Centre Lareb
Website/Homepagewww.lareb.nl
Details of (Primary) lead investigator
Title Dr
Last name Kant
First name Agnes
Is this study being carried out with the collaboration of a research network?
Yes
EU PE&PV research network
Other centres where this study is being conducted
Multiple centres

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

Federal Agency for Medicines and Health Products (FAHMP), Belgium
University of Verona, Italy
Paul Ehrlich Institute (PEI), Germany
HALMED, Croatia
Countries in which this study is being conducted
International study

Belgium
Croatia
France
Germany
Italy
Luxembourg
Netherlands
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed11/12/202011/12/2020
Start date of data collection01/02/202115/12/2020
Start date of data analysis
Date of interim report, if expected06/04/2022
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 Dr
Last name Kant
First name Agnes
Address line 1Goudsbloemvallei 7
Address line 2 
Address line 3 
City's-Hertogenbosch 
Postcode5237MH 
CountryNetherlands
Phone number (incl. country code)31-73-6469700 
Alternative phone number 
Fax number (incl. country code)31-73-6426136 
Email address a.kant@lareb.nl
Public Enquiries
Title Dr 
Last name Kant 
First name Agnes 
Address line 1Goudsbloemvallei 7 
Address line 2 
Address line 3 
City's-Hertogenbosch 
Postcode5237MH 
CountryNetherlands 
Phone number (incl. country code)31-73-6469700 
Alternative phone number 
Fax number (incl. country code)31-73-6426136 
Email address a.kant@lareb.nl 
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