The feasibility of pragmatic influenza vaccine randomized controlled real-world trials in Denmark and England
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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.
| Originalsprog | Engelsk |
|---|---|
| Artikelnummer | 25 |
| Tidsskrift | npj Vaccines |
| Vol/bind | 7 |
| Udgave nummer | 1 |
| Sider (fra-til) | 1-9 |
| DOI | |
| Status | Udgivet - 2022 |
Bibliografisk note
Funding Information:
The authors would like to thank Camille Salamand and Celine Monfredo of Sanofi Pasteur for statistical advice and development of Fig. 4. Eleanor Axson, Daniel Dedman, Arlene Gallagher, Tarita Murray-Thomas, Stephen Welburn and Achim Wolf of CPRD are thanked for contributions to data access and management, quality assurance and interpretation of findings. This study is based in part on data from the Clinical Practice Research Datalink obtained under license from the UK Medicines and Healthcare products Regulatory Agency. The data is provided by patients and collected by the NHS as part of their care and support. The interpretation and conclusions contained in this study are those of the author/s alone. The study was funded by Sanofi Pasteur. Sponsor staff were involved in all aspects of data collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the paper for publication.
Funding Information:
The authors would like to thank Camille Salamand and Celine Monfredo of Sanofi Pasteur for statistical advice and development of Fig. 4. Eleanor Axson, Daniel Dedman, Arlene Gallagher, Tarita Murray-Thomas, Stephen Welburn and Achim Wolf of CPRD are thanked for contributions to data access and management, quality assurance and interpretation of findings. This study is based in part on data from the Clinical Practice Research Datalink obtained under license from the UK Medicines and Healthcare products Regulatory Agency. The data is provided by patients and collected by the NHS as part of their care and support. The interpretation and conclusions contained in this study are those of the author/s alone. The study was funded by Sanofi Pasteur. Sponsor staff were involved in all aspects of data collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the paper for publication.
Funding Information:
J.N., D.R., H.B. and S.C. are employees of Sanofi Pasteur, a company which makes influenza vaccines. H.Bo, R.E.G., H.S., R.W. and E.Y. are employees of Clinical Practice Research Datalink. CPRD is jointly sponsored by the UK government’s Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health Research (NIHR). As a not-for-profit UK government body, CPRD seeks to recoup the cost of delivering its research services to academic, industry, and government researchers through research user license fees. The remaining authors declare no competing interests.
Publisher Copyright:
© 2022, The Author(s).
ID: 311115576