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
| 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 |
| 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 |
