N/A
N=24
Risk of Narcolepsy Associated With Administration of H1N1 Vaccine
Narcolepsy
Bottom Line
View on ClinicalTrials.gov: NCT01394614 ↗Enrolled (actual)
24
Serious AEs
—
Results posted
Apr 2015
Primary outcome: Primary: Incidence of Narcolepsy Among Narcoleptic Subjects Exposed or Unexposed to Vaccine — 0.52; 0.11 events per 100,000 person-years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- A/H1N1 vaccine (Biological)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Narcolepsy Among Narcoleptic Subjects Exposed or Unexposed to Vaccine |
0.52; 0.11 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subjects with symptoms of narcolepsy with onset during the period between January 1st, 2009 and December 31, 2010.
Exclusion Criteria
- Subjects younger than 6 months of age
Data sourced from ClinicalTrials.gov (NCT01394614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.