Trial reportHuman vaccines & immunotherapeutics2018
Feasibility of a cluster-randomized influenza vaccination trial in U.S. nursing homes: Lessons learned.
Trial report in Human vaccines & immunotherapeutics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 4 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 4 syntheses or guidelines pooled it, 37 citations in OpenAlex.
- High-Dose vs Standard-Dose Influenza Vaccines in Older Adults: A Meta-Analysis.JAMA network open · 2026Pooled it
- Trivalent and quadrivalent seasonal influenza vaccine in adults aged 60 and older: a systematic review and network meta-analysis.BMJ evidence-based medicine · 2024Pooled it
- Systematic review of influenza vaccine effectiveness against laboratory-confirmed influenza among older adults living in aged care facilities.Human vaccines & immunotherapeutics · 2023Pooled it
- Pooled it
- High-Dose vs. Standard-Dose Influenza Vaccine in Older Patients With Hypertension: A Post Hoc Analysis of DANFLU-1.Journal of clinical hypertension (Greenwich, Conn.) · 2025Trial
- High-Dose Quadrivalent Influenza Vaccine for Prevention of Cardiovascular and Respiratory Hospitalizations in Older Adults.Influenza and other respiratory viruses · 2024Trial
- Evaluation of emergency medical responses to nursing homes in a local area of Germany.BMC emergency medicine · 2025Article
- Article
- Protecting the elderly from influenza in the context of immune system senescence. Elderly aged 65 and over are vulnerable to influenza and its associated complications.: Position paper by the Romanian Society of Gerontology and Geriatrics.Journal of medicine and life · 2024Article
- Evidence-time dilemma in a pandemic with high mortality: Can outcome-driven decision making on vaccines prevent deaths?Clinical and translational science · 2022Article
- Article
- Article
- [High-dose trivalent influenza vaccine. Efficacy and effectiveness].Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2020Review
- Statistical Considerations for Embedded Pragmatic Clinical Trials in People Living with Dementia.Journal of the American Geriatrics Society · 2020Article
- Barriers and facilitators to implementing a pragmatic trial to improve advance care planning in the nursing home setting.BMC health services research · 2019Article
- Alternative-Dose versus Standard-Dose Trivalent Influenza Vaccines for Immunocompromised Patients: A Meta-Analysis of Randomised Control Trials.Journal of clinical medicine · 2019Article
- 100 years since the 1918 influenza pandemic.Human vaccines & immunotherapeutics · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Influenza severity increases and vaccine effectiveness decreases with age. High-dose influenza vaccine (HD) with quadruple the antigen of standard-dose (SD) vaccine is more efficacious in community-dwelling persons 65 years and older. We evaluated the feasibility of recruiting and randomizing Medicare certified nursing homes (NHs) for a pragmatic cluster-randomized trial comparing HD vs. SD (NCT1720277). Residents were long-stay and at least 65 years old. NH leadership agreed to standard of care random assignment with HD (Fluzone® High-Dose) or SD (Fluzone®) influenza vaccine for their facility for the 2012-2013 influenza season. We used Minimum Data Set (MDS) 3.0 and Vital Status records for pre-specified clinical outcomes: 1) all-cause hospitalization, 2) NH mortality, and 3) functional decline. Intent-to-treat analyses were performed at the resident-level using Cox proportional hazards, multivariable Poisson, and logistic regression models accounting for clustering by facility. We randomized 39 NHs (19 SD and 20 HD), coordinated vaccine delivery, implemented web-based data collection, and accessed MDS data, demonstrating feasibility. There were 2,957 eligible residents (SD 1496; HD 1461); characteristics were similar between groups. A total of 301 (20.1%) of SD and 197 (13.5%) of HD allocated residents were ever hospitalized, (adjusted relative risk 0.680; 95% CI: 0.537, 0.862; p = 0.001). NH mortality was 274 (18.3%) SD vs. 249 (17.1%) HD, adjusted relative risk 0.834; 95% CI: 0.678, 1.027; p = 0.087). There were no differences in decline in functional status (13.4 vs. 13.8%, adjusted relative risk 0.994; 95% CI: 0.774,1.278; p = 0.965). We demonstrate that a pragmatic large-scale trial is feasible in a NH setting.
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