A pragmatic randomized feasibility trial of influenza vaccines
<p><strong>Background: </strong>The relative vaccine effectiveness (rVE) of high-dose quadrivalent influenza vaccines (QIV-HD) versus standard-dose quadrivalent influenza vaccines (QIV-SD) against hospitalizations and mortality in the general older population has not been...
| Main Authors: | , , , , , , , , , , , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
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Massachusetts Medical Society
2023
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| _version_ | 1797110166399746048 |
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| author | Johansen, ND Modin, D Nealon, J Samson, S Salamand, C Loiacono, MM Larsen, CS Jensen, AMR Landler, NE Claggett, BL Solomon, SD Landray, MJ Gislason, GH Køber, L Jensen, JUS Sivapalan, P Vestergaard, LS Valentiner-Branth, P Krause, TG Biering-Sørensen, T |
| author_facet | Johansen, ND Modin, D Nealon, J Samson, S Salamand, C Loiacono, MM Larsen, CS Jensen, AMR Landler, NE Claggett, BL Solomon, SD Landray, MJ Gislason, GH Køber, L Jensen, JUS Sivapalan, P Vestergaard, LS Valentiner-Branth, P Krause, TG Biering-Sørensen, T |
| author_sort | Johansen, ND |
| collection | OXFORD |
| description | <p><strong>Background: </strong>The relative vaccine effectiveness (rVE) of high-dose quadrivalent influenza vaccines (QIV-HD) versus standard-dose quadrivalent influenza vaccines (QIV-SD) against hospitalizations and mortality in the general older population has not been evaluated in an individually randomized trial. Because of the large sample size required, such a trial will need to incorporate innovative, pragmatic elements.</p>
<p><strong>Methods: </strong>We conducted a pragmatic, open-label, active-controlled, randomized feasibility trial in Danish citizens aged 65 to 79 years during the 2021–2022 influenza season. Participants were randomly assigned 1:1 to receive QIV-HD or QIV-SD. Randomization was integrated into routine vaccination practice, and the trial relied solely on nationwide administrative health registries for data collection. Outcomes consisted of a feasibility assessment and descriptive rVE estimates.</p>
<p><strong>Results: </strong>We invited 34,000 persons to participate. A total of 12,477 randomly assigned participants were included in the final analyses. Mean (±SD) age was 71.7±3.9 years, and 5877 (47.1%) were women. Registry-based data collection was feasible, with complete follow-up data for 99.9% of participants. Baseline characteristics were comparable to those of the overall Danish population aged 65 to 79 years. The incidence of hospitalization for influenza or pneumonia was 10 (0.2%) of 6245 in the QIV-HD group and 28 (0.4%) of 6232 in the QIV-SD group (rVE, 64.4%; 95% confidence interval, 24.4 to 84.6). All-cause death occurred in 21 (0.3%) and 41 (0.7%) participants in the QIV-HD and QIV-SD groups, respectively (rVE, 48.9%; 95% confidence interval, 11.5 to 71.3).</p>
<p><strong>Conclusions: </strong>Conducting a pragmatic randomized trial of QIV-HD versus QIV-SD using existing infrastructure and registry-based data collection was feasible. The findings of lower incidence of hospitalization for influenza or pneumonia and all-cause mortality in the QIV-HD group compared with the QIV-SD group require replication in a future, fully powered trial. (Funded by Sanofi; ClinicalTrials.gov number, NCT05048589.)</p> |
| first_indexed | 2024-03-07T07:51:43Z |
| format | Journal article |
| id | oxford-uuid:5c283b0f-f28f-4b3e-bb87-3073033299df |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T07:51:43Z |
| publishDate | 2023 |
| publisher | Massachusetts Medical Society |
| record_format | dspace |
| spelling | oxford-uuid:5c283b0f-f28f-4b3e-bb87-3073033299df2023-07-24T07:08:47ZA pragmatic randomized feasibility trial of influenza vaccinesJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:5c283b0f-f28f-4b3e-bb87-3073033299dfEnglishSymplectic ElementsMassachusetts Medical Society2023Johansen, NDModin, DNealon, JSamson, SSalamand, CLoiacono, MMLarsen, CSJensen, AMRLandler, NEClaggett, BLSolomon, SDLandray, MJGislason, GHKøber, LJensen, JUSSivapalan, PVestergaard, LSValentiner-Branth, PKrause, TGBiering-Sørensen, T<p><strong>Background: </strong>The relative vaccine effectiveness (rVE) of high-dose quadrivalent influenza vaccines (QIV-HD) versus standard-dose quadrivalent influenza vaccines (QIV-SD) against hospitalizations and mortality in the general older population has not been evaluated in an individually randomized trial. Because of the large sample size required, such a trial will need to incorporate innovative, pragmatic elements.</p> <p><strong>Methods: </strong>We conducted a pragmatic, open-label, active-controlled, randomized feasibility trial in Danish citizens aged 65 to 79 years during the 2021–2022 influenza season. Participants were randomly assigned 1:1 to receive QIV-HD or QIV-SD. Randomization was integrated into routine vaccination practice, and the trial relied solely on nationwide administrative health registries for data collection. Outcomes consisted of a feasibility assessment and descriptive rVE estimates.</p> <p><strong>Results: </strong>We invited 34,000 persons to participate. A total of 12,477 randomly assigned participants were included in the final analyses. Mean (±SD) age was 71.7±3.9 years, and 5877 (47.1%) were women. Registry-based data collection was feasible, with complete follow-up data for 99.9% of participants. Baseline characteristics were comparable to those of the overall Danish population aged 65 to 79 years. The incidence of hospitalization for influenza or pneumonia was 10 (0.2%) of 6245 in the QIV-HD group and 28 (0.4%) of 6232 in the QIV-SD group (rVE, 64.4%; 95% confidence interval, 24.4 to 84.6). All-cause death occurred in 21 (0.3%) and 41 (0.7%) participants in the QIV-HD and QIV-SD groups, respectively (rVE, 48.9%; 95% confidence interval, 11.5 to 71.3).</p> <p><strong>Conclusions: </strong>Conducting a pragmatic randomized trial of QIV-HD versus QIV-SD using existing infrastructure and registry-based data collection was feasible. The findings of lower incidence of hospitalization for influenza or pneumonia and all-cause mortality in the QIV-HD group compared with the QIV-SD group require replication in a future, fully powered trial. (Funded by Sanofi; ClinicalTrials.gov number, NCT05048589.)</p> |
| spellingShingle | Johansen, ND Modin, D Nealon, J Samson, S Salamand, C Loiacono, MM Larsen, CS Jensen, AMR Landler, NE Claggett, BL Solomon, SD Landray, MJ Gislason, GH Køber, L Jensen, JUS Sivapalan, P Vestergaard, LS Valentiner-Branth, P Krause, TG Biering-Sørensen, T A pragmatic randomized feasibility trial of influenza vaccines |
| title | A pragmatic randomized feasibility trial of influenza vaccines |
| title_full | A pragmatic randomized feasibility trial of influenza vaccines |
| title_fullStr | A pragmatic randomized feasibility trial of influenza vaccines |
| title_full_unstemmed | A pragmatic randomized feasibility trial of influenza vaccines |
| title_short | A pragmatic randomized feasibility trial of influenza vaccines |
| title_sort | pragmatic randomized feasibility trial of influenza vaccines |
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