ITMO public health
Last update : 08/17/2016 | Version : 1 | ID : 73060
| General | |
| Identification | |
| Detailed name | Case-Control Study on Narcolepsy Risk Factors Following Exposure to Anti-H1N1 Vaccines |
| Sign or acronym | NarcoFluVF |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL No. 911190; CPP: DC2011/18 (23/02/11) |
| General Aspects | |
| Medical area |
Infectious diseases Neurology |
| Pathology (details) | Narcolepsy |
| Health determinants |
Iatrogenic |
| Keywords | narcolepsy, H1N1, influenza, vaccines, exposure |
| Scientific investigator(s) (Contact) | |
| Name of the director | Pariente |
| Surname | Antoine |
| Phone | +33 (0)5 57 57 46 75 |
| antoine.pariente@u-bordeaux2.fr | |
| Unit | Pharmacoepidemiology |
| Organization | Inserm, Bordeaux University Hospital |
| Name of the director | Dauvilliers |
| Surname | Yves |
| Phone | +33 (0)4 67 33 74 78 |
| y-dauvilliers@chu-montpellier.fr | |
| Unit | National Reference Centre for Narcolepsy/Sleep Laboratory |
| Organization | Montpellier University Hospital |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | VAESCO European Project |
| Funding | |
| Funding status |
Public |
| Details | ANSM, ECDC |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Inserm |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | Bordeaux University |
| Organisation status |
Public |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Case control 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: |
Another treatment or procedure |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective |
The main aim of the study was to determine the risk factors for narcolepsy; particularly focussing on the potential impact of influenza, H1N1 infection and vaccination (especially against the H1N1 influenza pandemic). As such, the study was able to contribute to the European study coordinated by the VAESCO consortium and received funding from the ECDC.
The secondary aim was to compare the characteristics of exposed and unexposed cases. The potential impact of genetic susceptibility is not outlined in the final report (depending on the analyses that will potentially be carried out on stored samples). |
| Inclusion criteria |
Cases were defined as patients diagnosed with narcolepsy; validated and classed according to the Brighton Classification Criteria by an approval committee; with an index date between 01/04/2009 and 30/04/2011, and where the onset of excessive daytime sleepiness (EDS) occurred before 31/12/2004.
Controls: Patients of the same age, sex and treated at the same centre as the case subject. Treatment unrelated to narcolepsy or anti-H1N1 vaccination. |
| 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 |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | 14 centres across France. |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2011 |
| Date of last collection (YYYY or MM/YYYY) | 2012 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | Case: 85; Controls: 202 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Declarative data Biological data Administrative data |
| Declarative data (detail) |
Face to face interview |
| Details of collected declarative data | Epworth Sleepiness Scale; demographic characteristics; medical history; immunisation history; viral and bacterial infection; treatment) |
| Biological data (detail) | Blood sample (HLA-DQB1 typing, genetic and antibody analyses). |
| Administrative data (detail) | Medical record |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Serum Plasma |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Data collection method | Face-to-face questionnaire for cases and by phone for cases and controls. |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=narcoflu |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Research may be included in scientific papers and publications following the express approval of the AFSSAPS. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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