The Risk of Narcolepsy Following Receipt of Adjuvanted Pandemic 2009 The Subtype of Influenza A Virus (H1N1) Vaccines: Results of the SOMNIA Global Collaborative Study
Notice bibliographique
Résumé
Background. An increased risk of narcolepsy following AS03-adjuvanted 2009 pandemic H1N1 influenza vaccine was observed in children in some countries in Europe, but the impact of media attention bias could not be excluded. The SOMNIA study was an international investigation of the association between AS03- and MF-59-adjuvanted monovalent pandemic H1N1 vaccines and narcolepsy. Methods. Objectives: To assess trends in narcolepsy incidence rates (IRs) before, during, and after the pandemic influenza (A)H1N1 vaccination campaigns and to perform a case-control study to estimate the relative risk of narcolepsy in children and adults for both MF-59 and AS03 adjuvanted pandemic (H1N1) 2009 vaccines. A dynamic retrospective cohort study was conducted to estimate incidence rates of narcolepsy diagnoses using a common protocol on electronic data in 7 countries during 2003–2013. For the case control study, conducted according to a common protocol in 6 countries, cases were identified from sleep center records. The referral date for the sleep latency test was the index date. Controls were matched for country, age, sex, and index date. Conditional logistic regression was used to estimate the odds ratio of narcolepsy with AS03 and MF59 containing H1N1 vaccines. Results. No changes in incidence rates of narcolepsy diagnoses were observed between the period after the start of AS03- or MF-59-containing H1N1 vaccination programs and the period before H1N1 circulation, in any of the age groups or countries except for Sweden, where a steep increase was observed in children 5-19 years in 2010. In the primary case control analysis, no association was observed for AS03-containing vaccines in children or adults. Based on three exposed cases, an association with MF-59 vaccine was observed in Argentina in the primary analysis in children, but no association was found when cases from Europe were included. Conclusion. Overall, our results do not support an association between receipt of AS03-adjuvanted 2009 H1N1 vaccine and narcolepsy although our results are based almost exclusively on Arepanrix use in Ontario. Power to assess risk following MF-59 vaccine was limited. Funding. The study is funded by the Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, USA, under CDC contract number 200-2012-53425_addendum 0001. Disclosures. S. Black, GSK Vaccines: Scientific Advisor, Consulting fee
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,010 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,000 | 0,000 |
| Bibliométrie | 0,000 | 0,002 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,002 | 0,001 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».