Risk of Narcolepsy Associated With Administration of H1N1 Vaccine
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Risk of Narcolepsy Associated With Administration of Inactivated Adjuvanted (AS03) A/H1N1 Pandemic Influenza Vaccine in Quebec|
- Incidence of Narcolepsy Among Narcoleptic Subjects Exposed or Unexposed to Vaccine [ Time Frame: Narcolepsy onset during the 16-week post-vaccination period. ] [ Designated as safety issue: Yes ]Incidence rates will be computed by comparing narcolepsy incidence rates in exposed and non-exposed subjects. Comparison of narcolepsy incidence rates in the period prior to vaccine administration and pseudo-vaccine administration will be used to test the comparability of exposed and non-exposed group.
Biospecimen Retention: Samples With DNA
|Study Start Date:||June 2011|
|Study Completion Date:||November 2014|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Narcoleptics exposed to A/H1N1 vaccine
Adjuvanted (ASO3) A/H1N1 pandemic vaccine
Biological: A/H1N1 vaccine
Verify if exposure to Arepanrix vaccine increase risk of developing narcolepsy in 16 weeks post-vaccination.
Other Name: Arepanrix vaccine
Narcoleptics unexposed to A/H1N1 vaccine
Narcoleptic subjects who were unexposed (non-vaccinated or vaccinated after onset) to adjuvanted (ASO3) A/H1N1 pandemic vaccine.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01394614
|Montreal, Quebec, Canada, H4J 1C5|
|Principal Investigator:||Jacques Montplaisir, MD, PhD||Sacre-Coeur Hospital|