EVANESCO - Cohort Event monitoring of COVID-19 vAcciNE Safety in France using patient-reported outCOmes

Head :
Thurin Nicolas, Bordeaux PharmacoEpi (BPE) Research Platform - Inserm CIC1401

Last update : 01/27/2023 | Version : 2 | ID : 73996

print
Print
xml
XML

Export to XML

Please choose the format :

pdf
PDF
xml
CSV (Excel)

Export to CSV

What sections do you want to export ?

Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
Select all | Invert selection | No selection

Which version do you want to export ?

send
Send
General
Identification
Detailed name Cohort Event monitoring of COVID-19 vAcciNE Safety in France using patient-reported outCOmes
Sign or acronym EVANESCO
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation ID-RCB : 2020-A03554-35; CPP : 21.01.14.466.31
General Aspects
Medical area Infectious diseases
Study in connection with Covid-19 Yes
Pathology (details) Patient-reported adverse drug reactions following COVID-19 vaccination
Health determinants Iatrogenic
Medicine
Keywords COVID-19, vaccines, adverse drug reactions
Scientific investigator(s) (Contact)
Name of the director Thurin
Surname Nicolas
Address Bordeaux PharmacoEpi - INSERM CIC1401
Université de Bordeaux
Bâtiment Le Tondu - Case 41
146, Rue Léo Saignat
33076 BORDEAUX Cedex
Unit Bordeaux PharmacoEpi (BPE) Research Platform - Inserm CIC1401
Organization University of Bordeaux
Collaborations
Participation in projects, networks and consortia Yes
Details European consortium coordinated by Utrecht University, Netherlands; Participant Centres: Pharmacovigilance Centre LAREB, Netherlands; Federal Agency for Medicines and Health Products, Belgium; Luxembourg Institute of Health, Luxembourg; University of Verona, Italy; University of Bordeaux, France; DSRU, England; Paul Ehrlich Institute, Germany; HALMED, Croatia
Funding
Funding status Public
Details EMA and the French Ministry of Health
Governance of the database
Sponsor(s) or organisation(s) responsible University of Bordeaux, Bordeaux PharmacoEpi (BPE) Research Platform Inserm CIC1401
Organisation status Both
Presence of scientific or steering committees No
Additional contact
Name of the contact Dureau-Pournin
Surname Caroline
Address Bordeaux PharmacoEpi - INSERM CIC1401
Université de Bordeaux
Bâtiment Le Tondu - Case 41
146, Rue Léo Saignat
33076 BORDEAUX Cedex
Email caroline.dureau@u-bordeaux.fr
Unit Bordeaux PharmacoEpi (BPE) Research Platform - Inserm CIC1401
Organization University of Bordeaux
Main features
Type of database
Type of database Study databases
Study databases (details) Cohort study
Database recruitment is carried out by an intermediary A selection of health institutions and services
Database recruitment is is made on the basis of: Medication(s) taken
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. Recruitment of participants at vaccination centres and pharmacies with collection of primary data directly from individuals vaccinated against COVID-19 via a dedicated secure online application.
Database objective
Main objective To generate incidence rates of patient-reported Adverse Drug Reaction (ADR) of brand specific COVID-19 vaccination in France, in near real time.
Inclusion criteria - To describe ADR incidence rates according to brand of vaccine and to specific populations such as, pregnant women, patients with severe co-morbidities (e.g., frail, vaccinees with auto-immune diseases), elderly, children, patients having recently received other vaccines;
- To detect potential novel safety signals;
- To identify possible risk factors for ADR.
Population type
Age Childhood (6 to 13 years)
Adolescence (13 to 18 years)
Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Great age (80 years and more)
Population covered General population
Pathology
Gender Male
Woman
Geography area National
Detail of the geography area Vaccination centers at the national level and pharmacies in Bordeaux agreeing to provide information on the study to those vaccinated.
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2021
Date of last collection (YYYY or MM/YYYY) 2023
Size of the database
Size of the database (number of individuals) [1000-10 000[ individuals
Details of the number of individuals 6,640 vaccinated individuals in France
Data
Database activity Current data collection
Type of data collected Declarative data
Declarative data (detail) Internet self-questionnaire
Details of collected declarative data Date of birth, gender, weight, height, name of vaccine, batch number, vaccination date, place of vaccination, medical history including previous COVID-19 infection, pregnancy, occupation if related to health care, medication taken, adverse reactions occurring after vaccination (type, date, duration, medication taken, examinations performed, seriousness, outcome, impact on daily life), COVID-19 infection after vaccination
Presence of a biobank No
Health parameters studied Health event/morbidity
Health event/mortality
Others
Other (detail) Adverse drug reactions occurring after vaccination against COVID-19
Procedures
Data collection method Data collection via a dedicated secure online application, with data entry by the vaccinated individuals.
Classifications used MedDRA coding of adverse reactions
Participant monitoring Yes
Monitoring procedures Monitoring by contact with the participant (mail, e-mail, telephone etc.)
Details on monitoring of participants Vaccinated individuals eceiving one dose of vaccine, 1st dose or booster dose, followed for 3 to 6 months via self-administered questionnaires to be completed by internet at inclusion, 1, 2, 6, 8 weeks, then 3 and 6 months, if applicable, after the start of the vaccination
Links to administrative sources Yes
Linked administrative sources (detail) SNDS, SI-Vaccine COVID and SI-DEP with 2 years of history and 1 year of follow-up: probabilistic chaining
Promotion and access
Promotion
Access

Partners - FAQ - Contact - Site map - Legal notices - Administration - Updated on December 15 2020 - Version 4.10.05