Risk of Narcolepsy Associated With Administration of H1N1 Vaccine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Hopital du Sacre-Coeur de Montreal.
Recruitment status was  Recruiting
Information provided by:
Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov Identifier:
First received: July 12, 2011
Last updated: July 13, 2011
Last verified: July 2011

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
Other: No intervention

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:
  • Risk of narcolepsy among vaccinated and non-vaccinated persons, adjusting for age and sex using the Mantel-Haenszel method [ Time Frame: Patients complete a 30-minute questionnaire with the sleep specialist and, if they agree to do the second portion, have a 24-hour investigation in the sleep lab. ] [ Designated as safety issue: Yes ]
    Risk ratios and attributable risks 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

Estimated Enrollment: 100
Study Start Date: June 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Narcoleptic subjects
Vaccinated and non-vaccinated narcoleptic subjects
Other: No intervention
No intervention

  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

Contact: Jacques Montplaisir, MD, PhD 514-338-2693 jy.montplaisir@umontreal.ca
Contact: Dominique Petit, PhD 514-338-2222 ext 3620 dominique.petit.1@umontreal.ca

Canada, Quebec
Sacre-Coeur Hospital Recruiting
Montreal, Quebec, Canada, H4J 1C5
Contact: Marie-Josée Quinn    514-338-2222 ext 3012    mj-quinn@crhsc.rtss.qc.ca   
Contact: Dominique Petit, PhD    514-338-2222 ext 3620    dominique.petit.1@umontreal.ca   
Principal Investigator: Jacques Montplaisir, MD, PhD         
Sponsors and Collaborators
Hopital du Sacre-Coeur de Montreal
Principal Investigator: Jacques Montplaisir, MD, PhD Sacre-Coeur Hospital
  More Information

No publications provided

Responsible Party: Jacques Montplaisir, MD, PhD, director of the Sleep Clinic, Sacre-Coeur Hospital
ClinicalTrials.gov Identifier: NCT01394614     History of Changes
Other Study ID Numbers: Narco-H1N1
Study First Received: July 12, 2011
Last Updated: July 13, 2011
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 March 25, 2015