Cohort Event monitoring of COVID-19 vAcciNE Safety in France using patient-reported outCOmes / Epidemiologie - France Portal

ITMO public health Aviesan

Records Cohort Event monitoring of...

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

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

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

Export to XML

Export to CSV

General

Main features

Data collection

Promotion and access

XXX