We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Risk of Narcolepsy Associated With Administration of H1N1 Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01394614
Recruitment Status : Completed
First Posted : July 14, 2011
Results First Posted : April 2, 2015
Last Update Posted : May 14, 2015
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Narcolepsy Biological: A/H1N1 vaccine

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 24 participants
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
Study Start Date : June 2011
Primary Completion Date : November 2014
Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Incidence of Narcolepsy Among Narcoleptic Subjects Exposed or Unexposed to Vaccine [ Time Frame: Narcolepsy onset during the 16-week post-vaccination period. ]
    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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: July 14, 2011    Key Record Dates
Results First Posted: April 2, 2015
Last Update Posted: May 14, 2015
Last Verified: May 2015

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

Additional relevant MeSH terms:
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Immunologic Factors
Physiological Effects of Drugs