Status: Finalised First registered on: 23/08/2021
Last updated on: 31/08/2023
1. Study identification
EU PAS Register NumberEUPAS42504
Official titleCohort Event Monitoring of safety of COVID-19 vaccines in special populations (pregnant and lactating women, children and adolescents, immunocompromised, people with history of allergy, people with prior SARS-CoV-2 infection)
Study title acronymCovid-Vaccine-Monitor CVM
Study typeObservational study
Brief description of the studyPrimary aim: To generate and compare incidence rates of patient-reported adverse reactions of different COVID-19 vaccines in pregnant and lactating women, children and adolescents, immunocompromised, people with history of allergy and people with prior SARS-CoV-2 infection Secondary aim: Within each special cohort of vaccinees to identify potential predictors of the most frequently reported adverse reactions related to different COVID-19 vaccines. The study is a prospective cohort study in special populations (pregnant and lactating women, children and adolescents, immunocompromised, people with history of allergy and people with prior SARS-CoV-2 infection). In different countries, on the national level, data will be prospectively collected, directly from a cohort of vaccine recipients. The common core data from different countries will be pooled, stratified by special cohort and analysed at the European level. The study is set up as a cohort monitoring for a duration of up until 6 months from the first dose vaccination date (except for pregnant women who will be followed up until 1.5 month after the pregnancy end).  Vaccine recipients should be asked to fill in questionnaires at baseline, and 1 and 3 weeks after the first dose (and eventually the second dose), and 3 and 6 months after first dose vaccination. As regards pregnant women a specific “End of Pregnancy” questionnaire will be additionally sent within 1.5 months from the estimated delivery to collect information on outcomes related to pregnancy and new-born. Safety data can be directly reported by vaccine recipients in their local language using the Lareb Intensive Monitoring (LIM) web app or the ResearchOnline web app. Collected data can be stored in dedicated central databases. For each special cohort, adverse reaction incidence rates will be reported overall and stratified and compared across different vaccine brands, gender, age groups, and countries.
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 nameUniversity of Verona
Centre locationPiazzale L. Scuro, 10 - 37134 Verona
Details of (Primary) lead investigator
Title Professor
Last name Trifirò
First name Gianluca
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?11

Pharmacol UNIVR
UMCU
Netherlands Pharmacovigilance Centre Lareb
CLPP Vaccines Network, Portugal
University of Medicine and Pharmacy ‘Iuliu Hatieganu’ Cluj-Napoca, Romania
Medical faculty of Pavol Jozef Safarik University SLOVACRIN), Slovakia
University of Verona, Italy
University of Bern, Switzerland
Rotunda Hospital Dublin, Ireland
ilmiovaccinoCOVID19 collaborating group, Italy
Countries in which this study is being conducted
International study

Ireland
Italy
Netherlands
Portugal
Romania
Slovakia
Spain
Switzerland
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed06/04/202106/04/2021
Start date of data collection07/07/202107/07/2021
Start date of data analysis30/09/2021
Date of interim report, if expected06/04/202208/04/2022
Date of final study report06/04/202308/05/2023
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 Trifirò
First name Gianluca
Address line 1Piazzale L. Scuro, 10
Address line 2 
Address line 3 
CityVerona 
Postcode37134 
CountryItaly
Phone number (incl. country code)390458124904 
Alternative phone number 
Fax number (incl. country code) 
Email address gianluca.trifiro@univr.it
Public Enquiries
Title Professor 
Last name Trifirò 
First name Gianluca 
Address line 1Piazzale L. Scuro, 10 
Address line 2 
Address line 3 
CityVerona 
Postcode37134 
CountryItaly 
Phone number (incl. country code)390458124904 
Alternative phone number 
Fax number (incl. country code) 
Email address gianluca.trifiro@univr.it 
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