A Pragmatic Randomized Feasibility Trial of Influenza Vaccines
A Pragmatic Randomized Feasibility Trial of Influenza Vaccines
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流感疫苗的务实随机可行性试验
DOI：
10.1056/evidoa2200206
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发表时间：
2023
期刊：
影响因子：
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通讯作者：
Johansen N
中科院分区：
文献类型：
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作者：
Johansen N
背景在一般老年人群中，高剂量四价流感疫苗（QIV-HD）与标准剂量四价流感疫苗（QIV-SD）对住院和死亡率的相对疫苗有效性（rVE）尚未在个体随机试验中进行评估。由于所需的大样本量，这样的试验将需要纳入创新，务实的elements.MethodsWe进行了一个务实的，开放标签，积极对照，随机可行性试验在丹麦公民年龄在65至79岁，在2021-2022年流感季节。参与者以1：1的比例随机分配接受QIV-HD或QIV-SD。随机化被整合到常规疫苗接种实践中，该试验仅依赖于全国性的行政卫生登记处进行数据收集。结果包括一个可行性评估和描述rVE estimates.ResultsWe邀请了34，000人参加。共有12，477名随机分配的参与者被纳入最终分析。平均（±SD）年龄为71.7±3.9岁，5877例（47.1%）为女性。基于登记册的数据收集是可行的，99.9%的参与者拥有完整的随访数据。基线特征与65至79岁的丹麦总人口的基线特征相当。QIV-HD组因流感或肺炎住院的发生率为10/6245（0.2%），QIV-SD组为28/6232（0.4%）（rVE，64.4%; 95%置信区间，24.4 - 84.6）。全因死亡发生在21（0.3%）和41（0.7%）的QIV-HD和QIV-SD组的参与者，分别（rVE，48.9%; 95%置信区间，11.5至71.3）。与QIV-SD组相比，QIV-HD组因流感或肺炎住院的发生率和全因死亡率较低，这一发现需要在未来的完全把握度试验中重复。（由赛诺菲资助; ClinicalTrials.gov编号，NCT 05048589。）
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.)