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Risk of Narcolepsy Associated With Administration of H1N1 Vaccine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01394614
First Posted: July 14, 2011
Last Update Posted: May 14, 2015
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.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Jacques Montplaisir, Hopital du Sacre-Coeur de Montreal
Results First Submitted: November 28, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Narcolepsy
Intervention: Biological: A/H1N1 vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Narcoleptic Subjects Exposed to Vaccine Exposed narcoleptic subjects (vaccinated and onset of narcolepsy is after vaccine administration)
Unexposed Narcoleptic Subjects Unexposed narcoleptic subjects (not vaccinated or vaccinated after the onset of symptoms)

Participant Flow:   Overall Study
    Narcoleptic Subjects Exposed to Vaccine   Unexposed Narcoleptic Subjects
STARTED   8   16 
COMPLETED   8   16 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Exposed Narcoleptic Subjects Exposed (vaccinated and onset of narcolepsy is after vaccine administration) narcoleptic subjects to adjuvanted A/H1N1 vaccine
Unexposed Narcoleptic Subjects Unexposed (non-vaccinated or vaccinated after onset of symptoms) narcoleptic subjects to adjuvanted A/H1N1 vaccine
Total Total of all reporting groups

Baseline Measures
   Exposed Narcoleptic Subjects   Unexposed Narcoleptic Subjects   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   16   24 
Age 
[Units: Participants]
     
<=18 years   6   7   13 
Between 18 and 65 years   2   9   11 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Full Range)
 19.9 
 (6 to 50) 
 26.1 
 (8 to 55) 
 24.0 
 (6 to 55) 
Gender 
[Units: Participants]
     
Female   6   6   12 
Male   2   10   12 
Region of Enrollment 
[Units: Participants]
     
Canada   8   16   24 


  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small number of subjects; Impossibility to completely exclude a confounding effect of the A/H1N1 virus infection itself.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Jacques Montplaisir
Organization: Center for Advanced Research in Sleep Medicine
phone: 514-388-2693
e-mail: jy.montplaisir@umontreal.ca


Publications:

Responsible Party: Jacques Montplaisir, Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov Identifier: NCT01394614     History of Changes
Other Study ID Numbers: Narco-H1N1
First Submitted: July 12, 2011
First Posted: July 14, 2011
Results First Submitted: November 28, 2014
Results First Posted: April 2, 2015
Last Update Posted: May 14, 2015