The feasibility of pragmatic influenza vaccine randomized controlled real-world trials in Denmark and England
Abstract 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 estimate...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Nature Portfolio
2022-02-01
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| Series: | npj Vaccines |
| Online Access: | https://doi.org/10.1038/s41541-022-00444-6 |
| _version_ | 1797430727919271936 |
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| author | Joshua Nealon Daniel Modin Rebecca E. Ghosh Deborah Rudin Gunnar Gislason Helen P. Booth Jens Ulrik Stæhr Jensen Rachael Williams Hilary Shepherd Eleanor Yelland Helene Bricout Sandra S. Chaves Tor Biering-Sørensen |
| author_facet | Joshua Nealon Daniel Modin Rebecca E. Ghosh Deborah Rudin Gunnar Gislason Helen P. Booth Jens Ulrik Stæhr Jensen Rachael Williams Hilary Shepherd Eleanor Yelland Helene Bricout Sandra S. Chaves Tor Biering-Sørensen |
| author_sort | Joshua Nealon |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-03-09T09:32:41Z |
| format | Article |
| id | doaj.art-352e38f5b37d4d6dbd8b143950a9a4e4 |
| institution | Directory Open Access Journal |
| issn | 2059-0105 |
| language | English |
| last_indexed | 2024-03-09T09:32:41Z |
| publishDate | 2022-02-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | npj Vaccines |
| spelling | doaj.art-352e38f5b37d4d6dbd8b143950a9a4e42023-12-02T03:20:07ZengNature Portfolionpj Vaccines2059-01052022-02-01711910.1038/s41541-022-00444-6The feasibility of pragmatic influenza vaccine randomized controlled real-world trials in Denmark and EnglandJoshua Nealon0Daniel Modin1Rebecca E. Ghosh2Deborah Rudin3Gunnar Gislason4Helen P. Booth5Jens Ulrik Stæhr Jensen6Rachael Williams7Hilary Shepherd8Eleanor Yelland9Helene Bricout10Sandra S. Chaves11Tor Biering-Sørensen12Sanofi Pasteur Medical Evidence GenerationDepartment of Cardiology, Copenhagen University Hospital—Herlev and GentofteClinical Practice Research Datalink, Medicines and Healthcare products Regulatory AgencySanofi Pasteur Global Medical AffairsDepartment of Cardiology, Copenhagen University Hospital—Herlev and GentofteClinical Practice Research Datalink, Medicines and Healthcare products Regulatory AgencyDepartment of Pulmonology, Copenhagen University Hospital—Herlev and Gentofte & Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of CopenhagenClinical Practice Research Datalink, Medicines and Healthcare products Regulatory AgencyClinical Practice Research Datalink, Medicines and Healthcare products Regulatory AgencyClinical Practice Research Datalink, Medicines and Healthcare products Regulatory AgencySanofi Pasteur Medical Evidence GenerationModelling, Epidemiology and Data Science, Sanofi PasteurDepartment of Cardiology, Copenhagen University Hospital—Herlev and GentofteAbstract 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.https://doi.org/10.1038/s41541-022-00444-6 |
| spellingShingle | Joshua Nealon Daniel Modin Rebecca E. Ghosh Deborah Rudin Gunnar Gislason Helen P. Booth Jens Ulrik Stæhr Jensen Rachael Williams Hilary Shepherd Eleanor Yelland Helene Bricout Sandra S. Chaves Tor Biering-Sørensen The feasibility of pragmatic influenza vaccine randomized controlled real-world trials in Denmark and England npj Vaccines |
| title | The feasibility of pragmatic influenza vaccine randomized controlled real-world trials in Denmark and England |
| title_full | The feasibility of pragmatic influenza vaccine randomized controlled real-world trials in Denmark and England |
| title_fullStr | The feasibility of pragmatic influenza vaccine randomized controlled real-world trials in Denmark and England |
| title_full_unstemmed | The feasibility of pragmatic influenza vaccine randomized controlled real-world trials in Denmark and England |
| title_short | The feasibility of pragmatic influenza vaccine randomized controlled real-world trials in Denmark and England |
| title_sort | feasibility of pragmatic influenza vaccine randomized controlled real world trials in denmark and england |
| url | https://doi.org/10.1038/s41541-022-00444-6 |
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