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

France, 2011 - 2012
Reference ID
FRESH-PEF73060-en
Producer(s)
Yves;DAUVILLIERS, Antoine;PARIENTE
Metadata
DDI/XML JSON
Study website Interactive tools
Created on
Feb 18, 2026
Last modified
Feb 18, 2026
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43
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Study authorization
  • Sampling
  • Survey instrument
  • Data collection
  • Study activities
  • Data Access
  • Contacts

    • Identification

    Survey ID number

    FRESH-PEF73060-en
    Title

    Case-Control Study on Narcolepsy Risk Factors Following Exposure to Anti-H1N1 Vaccines
    Abbreviation or Acronym

    NarcoFluVF
    Country
    Name Country code
    France fr
    Kind of Data

    ['Biological data','Socio-demographic data','Participant-reported health data']
    Unit of Analysis

    Individuals

    Scope

    Topics
    Topic Vocabulary
    Infectious disease medicine health theme
    Neurology health theme
    Narcolepsy cim-11
    Healthcare system determinants: Use of care health determinant
    Healthcare system determinants health determinant
    Keywords
    narcolepsy H1N1 influenza vaccines exposure

    Coverage

    Universe

    {"level_sex_clusion_I":[{"value":"Male","concept":{"vocab":"MeSH","vocabURI":"D008297"}},{"value":"Female","concept":{"vocab":"MeSH","vocabURI":"D005260"}}],"level_age_clusion_I":[{"value":"Child (6 to 12 years)","concept":{"vocab":"MeSH","vocabURI":"D002648"}},{"value":"Adolescent (13 to 18 years)","concept":{"vocab":"MeSH","vocabURI":"D000293"}},{"value":"Young Adult (19 to 24 years)","concept":{"vocab":"MeSH","vocabURI":"D055815"}},{"value":"Adult (25 to 44 years)","concept":{"vocab":"MeSH","vocabURI":"D000328"}},{"value":"Middle Aged (45 to 64 years)","concept":{"vocab":"MeSH","vocabURI":"D008875"}},{"value":"Aged (65 to 79 years)","concept":{"vocab":"MeSH","vocabURI":"D000368"}},{"value":"Aged, 80 and over (80 years and more)","concept":{"vocab":"MeSH","vocabURI":"D000369"}}],"level_type_clusion_I":"Patients population","level_type_clusion_other":"","clusion_I":"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.","clusion_E":""}

    Producers and sponsors

    Primary investigators
    Name
    Yves;DAUVILLIERS
    Antoine;PARIENTE
    Producers
    Name Role
    INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM) sponsor
    UNIVERSITE DE BORDEAUX sponsor
    Funding Agency/Sponsor
    Name
    AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)
    EUROPEAN CENTRE FOR DISEASE PREVENTION AND CONTROL
    Other Identifications/Acknowledgments
    Name
    VAESCO European Project

    Study authorization

    Agency
    Agency name
    CNIL
    CPP

    Sampling

    Sample frame

    Unit Type

    ['Through organizations (health services or institutions, schools, businesses, etc.)']
    Sampling Procedure

    ['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']

    Survey instrument

    Questionnaires

    Access on specific project only
    Methodology notes

    Observational Study

    Data collection

    Dates of Data Collection
    Start End
    2011-01-01 2012-01-01
    Mode of data collection
    • {"concept":{"vocabURI":"Interview","vocab":"CESSDA"},"value":"Interview with the participant (including clinical)"}

    Study activities

    Study activities
    Type
    primary evaluation
    Description
    Health event/morbidity

    Data Access

    Availability Status

    {"value":"Restricted access","extLink":[{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"}]}

    Contacts

    Contacts
    Name Email
    Yves;DAUVILLIERS y-dauvilliers@chu-montpellier.fr
    Antoine;PARIENTE antoine.pariente@u-bordeaux.fr
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