Clinical Trial: Risk of Narcolepsy Associated With Administration of H1N1 Vaccine

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Risk of Narcolepsy Associated With Administration of Inactivated Adjuvanted (AS03) A/H1N1 Pandemic Influenza Vaccine in Quebec

Brief Summary: 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.

Detailed Summary:

This study aims to describe the epidemiological and clinical characteristics of cases of narcolepsy which occurred in Quebec during the period 1 January 2009 to December 31, 2010 and to assess the risk of developing narcolepsy associated with the vaccine against influenza A/H1N1. The study will last about six months. Based on the prevalence of narcolepsy, an estimated 100 people who developed symptoms of narcolepsy between January 1st, 2009 and December 31, 2010 will participate in this study at the sleep clinic of the Sacré-Coeur Hospital in Montreal.

Narcolepsy is primarily characterized by the presence of excessive daytime sleepiness (EDS) and cataplexy. EDS occurs daily and is usually the most disabling symptom of narcolepsy. Cataplexy consists of a sudden drop of muscle tone triggered by strong and sudden emotions such as laughter, anger and surprise. Cataplexy is the most specific symptom of narcolepsy but it is not present in every patient especially at disease onset. Two other auxiliary symptoms are sleep paralysis and hypnagogic hallucinations either at sleep onset or upon awakening during the night or in the morning. They are present in approximately two thirds of narcoleptic patients especially in the younger individuals during the early stage of narcolepsy. Narcolepsy is associated with an absence or low level of hypocretin1 peptide in the cerebrospinal fluid (CSF).

Narcolepsy with cataplexy can be diagnosed purely on clinical grounds but this diagnosis should whenever possible be confirmed by night-time polysomnography (PSG) followed by the daytime multiple sleep latency test (MSLT). Sleep latency on the MSLT should be inferior or equal to 8 minutes with the presence of two or more sleep onset REM periods (SOREMPs). Human leukocyte antigen (HLA) typing of patients with narcolepsy-cataplexy almost always s
Sponsor: Hopital du Sacre-Coeur de Montreal

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

Original Primary Outcome: 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. ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Hopital du Sacre-Coeur de Montreal

Dates:
Date Received: July 12, 2011
Date Started: June 2011
Date Completion:
Last Updated: May 12, 2015
Last Verified: May 2015