| アブストラクト | We estimated the frequency of non-specific influenza-associated clinical endpoints to inform the feasibility of pragmatic randomized controlled trials (RCT) assessing relative vaccine effectiveness (rVE). Hospitalization rates of respiratory, cardiovascular and diabetic events were estimated from Denmark and England's electronic databases and stratified by age, comorbidity and influenza vaccination status. We included a seasonal average of 4.5 million Danish and 7.2 million English individuals, 17 and 32% with comorbidities. Annually, approximately 1% of Danish and 0.5% of English individuals were hospitalized for selected events, ~50% of them respiratory. Hospitalization rates were 40-50-fold and 2-10-fold higher in those >50 years and with comorbidities, respectively. Our findings suggest that a pragmatic RCT using non-specific endpoints is feasible. However, for outcomes with rates <2.5%, it would require randomization of ~100,000 participants to have the power to detect a rVE difference of ~13%. Targeting selected groups (older adults, those with comorbidities) where frequency of events is high would improve trial efficiency. |
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| ジャーナル名 | NPJ vaccines |
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| Pubmed追加日 | 2022/2/25 |
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| 投稿者 | Nealon, Joshua; Modin, Daniel; Ghosh, Rebecca E; Rudin, Deborah; Gislason, Gunnar; Booth, Helen P; Jensen, Jens Ulrik Staehr; Williams, Rachael; Shepherd, Hilary; Yelland, Eleanor; Bricout, Helene; Chaves, Sandra S; Biering-Sorensen, Tor |
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| 組織名 | Sanofi Pasteur Medical Evidence Generation, Lyon, France. jnealon@hku.hk.;School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong;Kong, Pokfulam, Hong Kong Special Administrative Region, Pokfulam, China.;jnealon@hku.hk.;Department of Cardiology, Copenhagen University Hospital-Herlev and Gentofte,;Copenhagen, Denmark.;Clinical Practice Research Datalink, Medicines and Healthcare products Regulatory;Agency, London, UK.;Sanofi Pasteur Global Medical Affairs, Swiftwater, PA, USA.;Department of Pulmonology, Copenhagen University Hospital-Herlev and Gentofte &;Department of Biomedical Sciences, Faculty of Health and Medical Sciences,;University of Copenhagen, Copenhagen, Denmark.;Sanofi Pasteur Medical Evidence Generation, Lyon, France.;Modelling, Epidemiology and Data Science, Sanofi Pasteur, Lyon, France. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/35197469/ |
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