ITMO public health
Last update : 06/26/2014 | Version : 1 | ID : 5440
| General | |
| Identification | |
| Detailed name | Vaccinology |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | EudraCT #: 2012-002139-27 |
| General Aspects | |
| Medical area |
Immunology |
| Health determinants |
Social and psychosocial factors |
| Others (details) | Influenza |
| Keywords | influenza, Vaccination, immunosenescence |
| Scientific investigator(s) (Contact) | |
| Name of the director | Nicolas |
| Surname | Jean-François |
| Address | Inserm Unité 1111 - CIRI - 21 avenue Tony Garnier - 69007 Lyon |
| Phone | +33 (0)4 37 28 23 48 |
| jean-francois.nicolas@chu-lyon.fr | |
| Unit | Equipe 14 Inserm U1111- CIRI "Immunologie de l'allergie cutanée et vaccination" |
| Organization | INSERM - Institut National de la Santé et de la Recherche |
| Name of the director | Rozières |
| Surname | Aurore |
| Address | Inserm Unité 1111 - CIRI - 21 avenue Tony Garnier - 69007 Lyon |
| Phone | +33 (0)4 37 28 23 48 |
| aurore.rozieres@inserm.fr | |
| Organization | INSERM - Institut National de la Santé et de la Recherche |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | Une sous partie de la cohorte (226 sujets) a fait partie d'une étude clinique financée par 2 partenaires industriels pour un projet labellisé Lyon Biopôle : Sanofi Pasteur et Becton Dickinson. Le reste a été financé sur les fonds propres de l'équipe. |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Allergobiotec hébergée chez INSERM - Institut National de la Santé et de la Recherche Médicale |
| Organisation status |
Public |
| Additional contact | |
| 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 carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | All patients vaccinated against influenza at the service participating in the clinical studies included in the funding returned to have blood samples taken and stored in the bio bank for the study of immunological markers. |
| Database objective | |
| Main objective | 1- To characterise immunity response to influenza vaccination in accordance with intradermal or intramuscular injection 2- To characterise immunosenescence markers in populations with no response to influenza vaccines |
| Inclusion criteria | 1) Over 65 years of age 2) Signed and dated consent 3) Able to attend all scheduled visits 4) Health insurance cover |
| Population type | |
| Age |
Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
General population |
| Gender |
Male Woman |
| Geography area |
Local |
| French regions covered by the database |
Auvergne Rhône-Alpes |
| Detail of the geography area | Lyon and Saint Étienne |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2010 |
| Date of last collection (YYYY or MM/YYYY) | 2013 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1126 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Biological data |
| Clinical data (detail) |
Direct physical measures |
| Declarative data (detail) |
Face to face interview |
| Biological data (detail) | Biological data related to inflammatory markers |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Serum Blood cells isolated Fluids (saliva, urine, amniotic fluid, …) Others |
| Details of biobank content | Serum, PBMCs |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Allergobiotec is responsible for cohort sample collection (Head Dr. Aurore Rozieres, INSERM U1111-CIRI/HCL). |
| Participant monitoring |
Yes |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data from this cohort is accessible through scientific publications. If other researchers wish to access this data, a request must be made and data will be made available according to good clinical practice. No "open access", filtered "access request". |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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