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
|Condition or disease||Intervention/treatment|
|Narcolepsy||Biological: A/H1N1 vaccine|
|Study Type :||Observational|
|Actual Enrollment :||24 participants|
|Official Title:||Risk of Narcolepsy Associated With Administration of Inactivated Adjuvanted (AS03) A/H1N1 Pandemic Influenza Vaccine in Quebec|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
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.
- 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
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
|Montreal, Quebec, Canada, H4J 1C5|
|Principal Investigator:||Jacques Montplaisir, MD, PhD||Sacre-Coeur Hospital|