Risk of Narcolepsy Associated With Administration of H1N1 Vaccine

This study has been completed.
Information provided by (Responsible Party):
Jacques Montplaisir, Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov Identifier:
First received: July 12, 2011
Last updated: May 12, 2015
Last verified: May 2015

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.

Condition Intervention
Biological: A/H1N1 vaccine

Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by Hopital du Sacre-Coeur de Montreal:

Primary Outcome Measures:
  • 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

HLA typing

Enrollment: 24
Study Start Date: June 2011
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Show Detailed Description


Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population includes persons more than 6 months of age residing in the province of Quebec.


Inclusion Criteria:

  • Subjects with symptoms of narcolepsy with onset during the period between January 1st, 2009 and December 31, 2010.

Exclusion Criteria:

  • Subjects younger than 6 months of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394614

Canada, Quebec
Sacre-Coeur Hospital
Montreal, Quebec, Canada, H4J 1C5
Sponsors and Collaborators
Hopital du Sacre-Coeur de Montreal
Principal Investigator: Jacques Montplaisir, MD, PhD Sacre-Coeur Hospital
  More Information

Responsible Party: Jacques Montplaisir, Director of the Sleep Clinic, Sacre-Coeur Hospital, Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov Identifier: NCT01394614     History of Changes
Other Study ID Numbers: Narco-H1N1
Study First Received: July 12, 2011
Results First Received: November 28, 2014
Last Updated: May 12, 2015
Health Authority: Canada: Health Canada

Keywords provided by Hopital du Sacre-Coeur de Montreal:
HLA typing
A/H1N1 vaccine

Additional relevant MeSH terms:
Disorders of Excessive Somnolence
Mental Disorders
Nervous System Diseases
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 09, 2015