Study identification

PURI

https://redirect.ema.europa.eu/resource/49318

EU PAS number

EUPAS39798

Study ID

49318

Official title and acronym

Cohort Event Monitoring of safety of COVID-19 vaccines (Early-) Covid-Vaccine-Monitor (Covid-Vaccine-Monitor ECVM CVM)

DARWIN EU® study

No

Study countries

Belgium
Croatia
France
Germany
Italy
Luxembourg
Netherlands
United Kingdom

Study description

Primary 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.

Study status

Finalised
Research institution and networks

Institutions

Federal Agency for Medicines and Health Products (FAHMP) Belgium, University of Verona Italy, Paul Ehrlich Institute (PEI) Germany, HALMED Croatia

Networks

Contact details

Agnes Kant

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
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_WP2_Protocol_v2.1_20210825

English (1.33 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