drugset / Trial / NCT02882100
Adjuvanted Influenza Vaccination in U.S. Nursing Homes
Phase 4
Completed
823 enrolled
Insight Therapeutics, LLC
Brown University · collabCase Western Reserve University · collabSeqirus · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
This study is powered to prospectively evaluate the relative effectiveness of adjuvanted trivalent influenza vaccine (aTIV; FLUAD) in preventing influenza mortality, hospitalization, and functional decline in a nursing home population in the U.S., compared to the commercially available, standard dose trivalent seasonal influenza vaccine (TIV; Fluvirin).
Timeline
- Start
- 2016-04
- Primary completion
- 2018-10-04
- Completion
- 2023-01-25
Publications
- Background Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, Fukuda K. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003 Jan 8;289(2):179-86. doi: 10.1001/jama.289.2.179.
- Background Thompson WW, Shay DK, Weintraub E, Brammer L, Bridges CB, Cox NJ, Fukuda K. Influenza-associated hospitalizations in the United States. JAMA. 2004 Sep 15;292(11):1333-40. doi: 10.1001/jama.292.11.1333.
- Background Hayward AC, Harling R, Wetten S, Johnson AM, Munro S, Smedley J, Murad S, Watson JM. Effectiveness of an influenza vaccine programme for care home staff to prevent death, morbidity, and health service use among residents: cluster randomised controlled trial. BMJ. 2006 Dec 16;333(7581):1241. doi: 10.1136/bmj.39010.581354.55. Epub 2006 Dec 1.
- Smith CL, Bednarchik B, Aung H, Wilk DJ, Boxer RS, Daddato AE, Wilson BM, Gravenstein S, Canaday DH. Humoral and Cellular Immunity Induced by Adjuvanted and Standard Trivalent Influenza Vaccine in Older Nursing Home Residents. J Infect Dis. 2023 Sep 15;228(6):704-714. doi: 10.1093/infdis/jiad071.
- Gravenstein S, McConeghy KW, Saade E, Davidson HE, Canaday DH, Han L, Rudolph J, Joyce N, Dahabreh IJ, Mor V. Adjuvanted Influenza Vaccine and Influenza Outbreaks in US Nursing Homes: Results From a Pragmatic Cluster-Randomized Clinical Trial. Clin Infect Dis. 2021 Dec 6;73(11):e4229-e4236. doi: 10.1093/cid/ciaa1916.
- McConeghy KW, Davidson HE, Canaday DH, Han L, Saade E, Mor V, Gravenstein S. Cluster-randomized Trial of Adjuvanted Versus Nonadjuvanted Trivalent Influenza Vaccine in 823 US Nursing Homes. Clin Infect Dis. 2021 Dec 6;73(11):e4237-e4243. doi: 10.1093/cid/ciaa1233.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluad | Vaccine | — | — |
| Subject | Influenza Virus Vaccine | Vaccine | — | — |