CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
A/H1N1 vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01394614
NCT01394614N/ACompleted
CompareCT.gov

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

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal·observational·Posted Jul 14, 2011·Updated May 14, 2015

In Brief

An observational study evaluating A/H1N1 vaccine for Narcolepsy. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsNarcolepsy
CountriesCanada
CollaboratorsGlaxoSmithKline

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 14, 2011
Enrollment StartJun 1, 2011
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 15.0 years ago

Interventions

A/H1N1 vaccinebiological

Verify if exposure to Arepanrix vaccine increase risk of developing narcolepsy in 16 weeks post-vaccination.