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
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 collection07/07/2021
Start date of data analysis
Date of interim report, if expected06/04/202208/04/2022
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 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)
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)
6. Study drug(s) information
Substance class (ATC Code)J07 (combinations)
7. Medical conditions to be studied
Medical condition(s)Yes
Immunocompromised
Allergic conditions
Pregnancy, puerperium and perinatal conditions
SARS-CoV-2 infection
8. Population under study
Age
Preterm newborns
Term newborns (0-27 days)
Infants and toddlers (28 days - 23 months)
Children (2 - 11 years)
Adolescents (12 - 17 years)
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
Other population
Renal impaired
Hepatic impaired
Immunocompromised
Pregnant women
9. Number of subjects
Estimated total number of subjects60000
Additional information
up to 60,000 participants: up to 30,000 pregnant and lactating women, up to 10,000 children, up to 20,000 immunocompromised, up to 10,000 persons with history of SARS-CoV-2 infection, and up to 5,000 with a history of allergies.
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Administrative database, e.g. claims database
Routine primary care electronic patient registry
11. Scope of the study
What is the scope of the study?
Risk assessment
Primary scope : Risk assessment
12. Main objective(s)
What is the main objective of the study?
To generate and compare incidence rates of patient-reported adverse reactions of different COVID-19 vaccines across the participating countries in pregnant and lactating women, children and adolescents, immunocompromised, people with history of allergy and people with prior SARS-CoV-2 infection
Are there primary outcomes?No
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
Around 1-7 months
15. Data analysis plan
Please provide a brief summary of the analysis method
Risk estimation: for each special cohort, a dedicated cumulative structured overview of numbers and incidence of all adverse reactions per vaccine will be provided, overall, and also stratified by vaccine brand, country, gender, and age group. For each adverse reaction, cumulative incidence with its 95% confidence interval (CI) will be reported by COVID-19 vaccine brand and dose.