A Pragmatic Randomized Feasibility Trial of Influenza Vaccines
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A Pragmatic Randomized Feasibility Trial of Influenza Vaccines. / Johansen, Niklas Dyrby; Modin, Daniel; Nealon, Joshua; Samson, Sandrine; Salamand, Camille; Loiacono, Matthew M.; Larsen, Carsten Schade; Jensen, Anne Marie Reimer; Landler, Nino Emanuel; Claggett, Brian L.; Solomon, Scott D.; Landray, Martin J.; Gislason, Gunnar H.; Køber, Lars; Jensen, Jens Ulrik Stæhr; Sivapalan, Pradeesh; Vestergaard, Lasse Skafte; Valentiner-branth, Palle; Krause, Tyra Grove; Biering-sørensen, Tor.
In: NEJM Evidence, Vol. 2, No. 2, 2023.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - A Pragmatic Randomized Feasibility Trial of Influenza Vaccines
AU - Johansen, Niklas Dyrby
AU - Modin, Daniel
AU - Nealon, Joshua
AU - Samson, Sandrine
AU - Salamand, Camille
AU - Loiacono, Matthew M.
AU - Larsen, Carsten Schade
AU - Jensen, Anne Marie Reimer
AU - Landler, Nino Emanuel
AU - Claggett, Brian L.
AU - Solomon, Scott D.
AU - Landray, Martin J.
AU - Gislason, Gunnar H.
AU - Køber, Lars
AU - Jensen, Jens Ulrik Stæhr
AU - Sivapalan, Pradeesh
AU - Vestergaard, Lasse Skafte
AU - Valentiner-branth, Palle
AU - Krause, Tyra Grove
AU - Biering-sørensen, Tor
PY - 2023
Y1 - 2023
N2 - BackgroundThe 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.MethodsWe 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.ResultsWe 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).ConclusionsConducting 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.)
AB - BackgroundThe 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.MethodsWe 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.ResultsWe 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).ConclusionsConducting 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.)
U2 - 10.1056/EVIDoa2200206
DO - 10.1056/EVIDoa2200206
M3 - Journal article
C2 - 38320035
VL - 2
JO - NEJM Evidence
JF - NEJM Evidence
SN - 2766-5526
IS - 2
ER -
ID: 395149830