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Risk of Narcolepsy Associated With Administration of H1N1 Vaccine

NCT01394614 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2015-05-14

Study results available
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Summary

The goal of the study is to assess the risk of occurrence of narcolepsy following the administration of inactivated (AS03) adjuvanted A/H1N1 pandemic influenza vaccine in the province of Quebec, Canada, using different case definitions and time intervals to disease onset, while controlling for potential confounding variables such as age, gender, season and, when possible, A/H1N1 pandemic influenza infection. Another aim is to describe the epidemiology and clinical features of narcolepsy cases with onset during the period January 1st, 2009 to December 31, 2010 in the population of Quebec.

Conditions

Interventions

BIOLOGICAL

A/H1N1 vaccine

Verify if exposure to Arepanrix vaccine increase risk of developing narcolepsy in 16 weeks post-vaccination.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

    lead OTHER

Principal Investigators

  • Jacques Montplaisir, MD, PhD · Sacre-Coeur Hospital

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01394614 on ClinicalTrials.gov