Evidence map›Paper›PMID 25264897›Full record

ArticlePloS one2014

Risk of narcolepsy associated with inactivated adjuvanted (AS03) A/H1N1 (2009) pandemic influenza vaccine in Quebec.

Jacques Montplaisir, Dominique Petit, Marie-Josée Quinn, Manale Ouakki, Geneviève Deceuninck, Alex Desautels, Emmanuel Mignot, Philippe De Wals

Registry-linked trialAbstract read
In one paragraph

Article in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01394614 (Risk of Narcolepsy Associated With Administration of Inactivated Adjuvanted), which is not on this map. Cited by 35 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01394614 completednot on this map

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

TypeobservationalSponsorCentre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealRan2011 to 2014Enrolled24ConditionsNarcolepsyArmsA/H1N1 vaccine
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Vaccines for preventing influenza in healthy adults.The Cochrane database of systematic reviews · 2018
    Pooled it
  4. Trial
  5. Observational
  6. The immunopathogenesis of narcolepsy type 1.Nature reviews. Immunology · 2024
    Review
  7. Review
  8. Review
  9. Article
  10. Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. No evidence of autoimmunity to human OXJournal of translational autoimmunity · 2020
    Article
  17. Article
  18. Review
  19. Autoimmunity to hypocretin and molecular mimicry to flu in type 1 narcolepsy.Proceedings of the National Academy of Sciences of the United States of America · 2018
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Jacques MontplaisirCentre for Advanced Research in Sleep Medicine, Hôpital du Sacré-Coeur, and Department of Psychiatry, University of Montreal, Montreal, Canada.
Dominique PetitCentre for Advanced Research in Sleep Medicine, Hôpital du Sacré-Coeur, Montreal, Canada.
Marie-Josée QuinnCentre for Advanced Research in Sleep Medicine, Hôpital du Sacré-Coeur, Montreal, Canada.
Manale OuakkiQuebec National Public Health Institute (Institut national de santé publique du Québec), Quebec City, Canada.
Geneviève DeceuninckQuebec University Hospital Research Centre, Quebec City, Canada.
Alex DesautelsCentre for Advanced Research in Sleep Medicine, Hôpital du Sacré-Coeur, and Department of Medicine, University of Montreal, Montreal, Canada.
Emmanuel MignotStanford Center for Sleep Sciences and Medicine, Stanford University of Medicine, Palo Alto, CA, United States of America.
Philippe De WalsDepartment of Social and Preventive Medicine, Laval University, Quebec City, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

contextAn association between an adjuvanted (AS03) A/H1N1 pandemic vaccine and narcolepsy has been reported in Europe.

objectiveTo assess narcolepsy risk following administration of a similar vaccine in Quebec.

designRetrospective population-based study.

settingNeurologists and lung specialists in the province were invited to report narcolepsy cases to a single reference centre. POPULATION: Patients were interviewed by two sleep experts and standard diagnostic tests were performed. Immunization status was verified in the provincial pandemic influenza vaccination registry.

main outcome measuresConfirmed narcolepsy with or without cataplexy with onset of excessive daytime sleepiness between January 1st, 2009, and December 31st, 2010. Relative risks (RRs) were calculated using a Poisson model in a cohort analysis, by a self-controlled case series (SCCS) and a case-control method.

resultsA total of 24 cases were included and overall incidence rate was 1.5 per million person-years. A cluster of 7 cases was observed among vaccinated persons in the winter 2009-2010. In the primary cohort analysis, 16-week post-vaccination RR was 4.32 (95% CI: 1.50-11.12). RR was 2.07 (0.70-6.17) in the SCCS, and 1.48 (0.37-7.03) using the case-control method. Estimates were lower when observation was restricted to the period of pandemic influenza circulation, and tended to be higher in persons <20 years old and for cataplexy cases.

conclusionsResults are compatible with an excess risk of approximately one case per million vaccine doses, mainly in persons less than 20 years of age. However, a confounding effect of the influenza infection cannot be ruled out.

Indexed as

Adjuvants, ImmunologicAdolescentAdultalpha-TocopherolCase-Control StudiesChildDrug CombinationsFemaleHumansInfluenza A Virus, H1N1 SubtypeInfluenza, HumanInfluenza VaccinesMaleMiddle AgedNarcolepsyPolysorbatesAdjuvants, Immunologicalpha-TocopherolAS03 adjuvantDrug CombinationsInfluenza VaccinesPolysorbatesSqualene

Identifiers

PMID25264897
PMCPMC4180737

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.