NarcoFluVF - Case-Control Study on Narcolepsy Risk Factors Following Exposure to Anti-H1N1 Vaccines

Head :
Pariente Antoine, Pharmacoepidemiology
Dauvilliers Yves, National Reference Centre for Narcolepsy/Sleep Laboratory

Last update : 08/17/2016 | Version : 1 | ID : 73060

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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
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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
Email 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
Email 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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