Study identification

PURI

https://redirect.ema.europa.eu/resource/47756

EU PAS number

EUPAS42504

Study ID

47756

Official title and acronym

Cohort 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) (Covid-Vaccine-Monitor CVM)

DARWIN EU® study

No

Study countries

Ireland
Italy
Netherlands
Portugal
Romania
Slovakia
Spain
Switzerland

Study description

Primary 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.

Study status

Finalised
Research institution and networks

Institutions

- 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

Networks

Contact details

Gianluca Trifirò

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

CVM_WP1_Protocol_v2.0_20210714_final

English (793.44 KB - PDF)View document
Updated protocol

CVM_WP1_Protocol_v2.1_20210729

English (1.42 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable