Evidence map›Paper›PMID 30122647›Full record

ArticleVaccine2018

Narcolepsy and adjuvanted pandemic influenza A (H1N1) 2009 vaccines - Multi-country assessment.

Daniel Weibel, Miriam Sturkenboom, Steven Black, Maria de Ridder, Caitlin Dodd, Jan Bonhoeffer, Ann Vanrolleghem, Nicoline van der Maas, Gert Jan Lammers, Sebastiaan Overeem and 29 more

Abstract read
In one paragraph

Article in Vaccine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Dispelling Vaccine Legal Myths.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2026
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  12. Cerebral venous sinus thrombosis due to vaccine-induced immune thrombotic thrombocytopenia in middle-income countries.International journal of stroke : official journal of the International Stroke Society · 2023
    Article
  13. Article
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  16. Characterization of T cell receptors reactive to HCRTProceedings of the National Academy of Sciences of the United States of America · 2022
    Article
  17. Article
  18. Pediatric Narcolepsy-A Practical Review.Children (Basel, Switzerland) · 2022
    Review
  19. Review
  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

39 authors.

Daniel WeibelMedical Informatics Department, Erasmus Medical Center, Rotterdam, The Netherlands. Electronic address: weibeldaniel@gmail.com.
Miriam SturkenboomJulius Global Health, University Utrecht Medical Center, Utrecht, The Netherlands.
Steven BlackCincinnati Children's Hospital, Cincinnati, OH, USA.
Maria de RidderMedical Informatics Department, Erasmus Medical Center, Rotterdam, The Netherlands.
Caitlin DoddMedical Informatics Department, Erasmus Medical Center, Rotterdam, The Netherlands.
Jan BonhoefferInfectiology and Vaccinology University Children's Hospital, Basel, Switzerland; Brighton Collaboration Foundation, Basel, Switzerland.
Ann VanrolleghemMedical Informatics Department, Erasmus Medical Center, Rotterdam, The Netherlands.
Nicoline van der MaasDept. Epidemiology and Surveillance, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
Gert Jan LammersLeiden University Medical Centre, Leiden, The Netherlands; Sleep-Wake Center SEIN, Heemstede, The Netherlands.
Sebastiaan OvereemSleep Medicine Centre Kempenhaeghe, Heeze, The Netherlands.
Angela GentileHospital de Niños Ricardo Gutiérrez, Ciudad Autónoma de Buenos Aires, Argentina.
Norberto GiglioHospital de Niños Ricardo Gutiérrez, Ciudad Autónoma de Buenos Aires, Argentina.
Vanesa CastellanoHospital de Niños Ricardo Gutiérrez, Ciudad Autónoma de Buenos Aires, Argentina.
Jeffrey C KwongInstitute for Clinical Evaluative Sciences (ICES), Ontario, Canada.
Brian J MurrayDivision of Neurology, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, Canada.
Karen Cauch-DudekInstitute for Clinical Evaluative Sciences (ICES), Ontario, Canada.
Diana JuhaszInstitute for Clinical Evaluative Sciences (ICES), Ontario, Canada.
Michael CampitelliInstitute for Clinical Evaluative Sciences (ICES), Ontario, Canada.
Alexandre N DattaUniversity Hospital Basel, Basel, Switzerland.
Ulf KallweitBern University Hospital and University of Bern, Bern, Switzerland; Witten/Herdecke University, Department of Rehabilitation, Witten/Herdecke, Germany.
Wan-Ting HuangTaiwan Centers for Disease Control, Taipei, Taiwan.
Yu-Shu HuangDepartment of Child Psychiatry and Sleep Center, Chang Gung Memorial Hospital and University, Taoyuan, Taiwan.
Chung-Yao HsuDepartment of Neurology and Sleep Disorders Center, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
Hsi-Chung ChenDepartment of Psychiatry and Center of Sleep Disorders, National Taiwan University Hospital, Taipei, Taiwan.
Maria Giner-SorianoInstitut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Barcelona, Spain.
Rosa MorrosInstitut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Barcelona, Spain.
Carles GaigNeurology Service and Multidisciplinary Sleep Disorders Unit, Hospital Clinic of Barcelona, Barcelona, Spain.
Ester TióAlthaia Xarxa Assistencial Universitària de Manresa, Neurology Service, Manresa, Barcelona, Spain.
Silvia Perez-VilarMedical Informatics Department, Erasmus Medical Center, Rotterdam, The Netherlands; Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat (FISABIO), Vaccine Research, Valencia, Spain.
Javier Diez-DomingoFundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat (FISABIO), Vaccine Research, Valencia, Spain.
Francisco Javier PuertasServicio de Neurofisiologia, Hospital Universitari de la Ribera, Valencia, Spain.
Lawrence W SvensonDivision of Preventive Medicine, University of Alberta, Alberta, Canada.
Salaheddin M MahmudVaccine and Drug Evaluation Centre, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Manitoba, Canada.
Bruce CarletonFaculty of Medicine, University of British Columbia, British Columbia, Canada.
Monika NausFaculty of Medicine, University of British Columbia, British Columbia, Canada.
Lisen Arnheim-DahlströmDepartment of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
Lars PedersenClinical Medicine/Epidemiology, Aarhus University, Aarhus, Denmark.
Frank DeStefanoCenters for Disease Control and Prevention (CDC), Immunization Safety Office, Atlanta, USA.
Tom T ShimabukuroCenters for Disease Control and Prevention (CDC), Immunization Safety Office, Atlanta, USA.

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

backgroundIn 2010, a safety signal was detected for narcolepsy following vaccination with Pandemrix, an AS03-adjuvanted monovalent pandemic H1N1 influenza (pH1N1) vaccine. To further assess a possible association and inform policy on future use of adjuvants, we conducted a multi-country study of narcolepsy and adjuvanted pH1N1 vaccines.

methodsWe used electronic health databases to conduct a dynamic retrospective cohort study to assess narcolepsy incidence rates (IR) before and during pH1N1 virus circulation, and after pH1N1 vaccination campaigns in Canada, Denmark, Spain, Sweden, Taiwan, the Netherlands, and the United Kingdom. Using a case-control study design, we evaluated the risk of narcolepsy following AS03- and MF59-adjuvanted pH1N1 vaccines in Argentina, Canada, Spain, Switzerland, Taiwan, and the Netherlands. In the Netherlands, we also conducted a case-coverage study in children born between 2004 and 2009.

resultsNo changes in narcolepsy IRs were observed in any periods in single study sites except Sweden and Taiwan; in Taiwan incidence increased after wild-type pH1N1 virus circulation and in Sweden (a previously identified signaling country), incidence increased after the start of pH1N1 vaccination. No association was observed for Arepanrix-AS03 or Focetria-MF59 adjuvanted pH1N1 vaccines and narcolepsy in children or adults in the case-control study nor for children born between 2004 and 2009 in the Netherlands case-coverage study for Pandemrix-AS03.

conclusionsOther than elevated narcolepsy IRs in the period after vaccination campaigns in Sweden, we did not find an association between AS03- or MF59-adjuvanted pH1N1 vaccines and narcolepsy in children or adults in the sites studied, although power to evaluate the AS03-adjuvanted Pandemrix brand vaccine was limited in our study.

Indexed as

Adjuvants, ImmunologicCase-Control StudiesHumansInfluenza A Virus, H1N1 SubtypeInfluenza, HumanInfluenza VaccinesNarcolepsyRetrospective StudiesVaccinationAdjuvants, ImmunologicarepanrixfocetriaInfluenza VaccinespandemrixAdjuvantAS03MF59NarcolepsyPandemic H1N1 influenza

Identifiers

PMID30122647
PMCPMC6404226

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Registered trials

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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.