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Risk of Narcolepsy Associated With Administration of H1N1 Vaccine

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ClinicalTrials.gov Identifier: NCT01394614
Recruitment Status : Completed
First Posted : July 14, 2011
Results First Posted : April 2, 2015
Last Update Posted : May 14, 2015
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Jacques Montplaisir, Hopital du Sacre-Coeur de Montreal

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Narcolepsy
Intervention Biological: A/H1N1 vaccine
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Narcoleptic Subjects Exposed to Vaccine Unexposed Narcoleptic Subjects
Hide Arm/Group Description Exposed narcoleptic subjects (vaccinated and onset of narcolepsy is after vaccine administration) Unexposed narcoleptic subjects (not vaccinated or vaccinated after the onset of symptoms)
Period Title: Overall Study
Started 8 16
Completed 8 16
Not Completed 0 0
Arm/Group Title Exposed Narcoleptic Subjects Unexposed Narcoleptic Subjects Total
Hide Arm/Group Description Exposed (vaccinated and onset of narcolepsy is after vaccine administration) narcoleptic subjects to adjuvanted A/H1N1 vaccine Unexposed (non-vaccinated or vaccinated after onset of symptoms) narcoleptic subjects to adjuvanted A/H1N1 vaccine Total of all reporting groups
Overall Number of Baseline Participants 8 16 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 16 participants 24 participants
<=18 years
6
  75.0%
7
  43.8%
13
  54.2%
Between 18 and 65 years
2
  25.0%
9
  56.3%
11
  45.8%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants 16 participants 24 participants
19.9
(6 to 50)
26.1
(8 to 55)
24.0
(6 to 55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 16 participants 24 participants
Female
6
  75.0%
6
  37.5%
12
  50.0%
Male
2
  25.0%
10
  62.5%
12
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 8 participants 16 participants 24 participants
8 16 24
1.Primary Outcome
Title Incidence of Narcolepsy Among Narcoleptic Subjects Exposed or Unexposed to Vaccine
Hide Description 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.
Time Frame Narcolepsy onset during the 16-week post-vaccination period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exposed Narcoleptic Subjects Unexposed Narcoleptic Subjects
Hide Arm/Group Description:

Exposed (vaccinated and onset of narcolepsy is post-vaccination) narcoleptic subjects

Intervention: Adjuvanted (ASO3) A/H1N1 pandemic vaccine Arepanrix.

Unexposed narcoleptic subjects (non-vaccinated or vaccinated after onset of symptoms)
Overall Number of Participants Analyzed 8 16
Measure Type: Number
Unit of Measure: events per 100,000 person-years
0.52 0.11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exposed Narcoleptic Subjects, Unexposed Narcoleptic Subjects
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence-rate difference
Estimated Value 0.41
Estimation Comments Difference between the incidence rate of exposed-to-vaccine cases (0.52) and that of unexposed cases (0.11) is 0.41 per 100,000 persons-years
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exposed Narcoleptic Subjects, Unexposed Narcoleptic Subjects
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 4.32
Confidence Interval (2-Sided) 95%
1.5 to 11.12
Estimation Comments Risk of developing narcolepsy if exposed to H1N1 vaccination (using the 16-week post-vaccination period as reference).
Time Frame Adverse Events were not reported since this was a retrospective study (only onset of narcolepsy, which is the main outcome, was reported)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Exposed Narcoleptic Subjects Unexposed Narcoleptic Subjects
Hide Arm/Group Description

Exposed narcoleptic subjects (vaccinated and onset of narcolepsy is post-vaccination)

Intervention: Adjuvanted (ASO3) A/H1N1 pandemic vaccine (Arepanrix)

Unexposed narcoleptic subjects (non-vaccinated or vaccinated after onset of symptoms)
All-Cause Mortality
Exposed Narcoleptic Subjects Unexposed Narcoleptic Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Exposed Narcoleptic Subjects Unexposed Narcoleptic Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Exposed Narcoleptic Subjects Unexposed Narcoleptic Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Small number of subjects; Impossibility to completely exclude a confounding effect of the A/H1N1 virus infection itself.
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
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