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Risk of Narcolepsy Associated With Administration of H1N1 Vaccine

This study is currently recruiting participants.
Verified July 2011 by Hopital du Sacre-Coeur de Montreal
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov Identifier:
NCT01394614
First received: July 12, 2011
Last updated: July 13, 2011
Last verified: July 2011
History of Changes
  Purpose

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
Narcolepsy
 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:

MedlinePlus related topics: Flu
U.S. FDA Resources

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

  Eligibility

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.

Criteria

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

Contacts
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

Locations
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
GlaxoSmithKline
Investigators
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:
Cataplexy
MSLT
Hypocretin
 HLA typing
Polysomnography
A/H1N1 vaccine

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

ClinicalTrials.gov processed this record on May 16, 2013