Relative Effectiveness of High-Dose Versus Standard-Dose Influenza Vaccination Against Hospitalizations and Deaths According to Frailty Score: A Post Hoc Analysis of the DANFLU-1 Randomized Trial
Abstract
Background: Frailty is a risk factor for adverse influenza-related outcomes. We assessed the effectiveness of high-dose inactivated influenza vaccination (HD-IIV) versus standard-dose inactivated influenza vaccination (SD-IIV) according to a frailty score.
Methods: This was a post hoc analysis of the randomized feasibility trial of HD-IIV versus SD-IIV conducted during the 2021-2022 influenza season in older adults aged 65-79 years. We assessed prespecified outcomes, including hospitalizations and deaths, as first and recurrent events. Frailty was defined according to the hospital frailty risk score (HFRS).
Results: Among 12 477 included participants (mean age, 71.7 years; 47.1% female), 10 689 (85.7%) were categorized as having low frailty (HFRS <5) and 1784 (14.3%) had intermediate or high frailty (HFRS ≥5). HD-IIV versus SD-IIV was associated with a lower risk of first and recurrent hospitalizations for pneumonia or influenza regardless of the HFRS. For participants with low frailty there were 22 events (hazard ratio [HR], 0.37 [95% confidence interval, .15-.96]) and 25 recurrent events (incidence rate ratio, 0.31 [.11-.84]), and for those with intermediate or high frailty there were 16 events (HR, 0.33 [.11-1.01]) and 18 recurrent events (incidence rate ratio, 0.28 [.09-.92]; P value for continuous interaction with HFRS [Pinteraction] = .92 for first and Pinteraction = .93 for recurrent events). The HFRS modified the association of HD-IIV versus SD-IIV with all-cause…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 12 participants or records.
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