Adjuvanted Influenza Vaccination in U.S. Nursing Homes
1 other identifier
interventional
823
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2016
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 24, 2016
CompletedFirst Posted
Study publicly available on registry
August 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2023
CompletedMarch 15, 2023
March 1, 2023
2.5 years
August 24, 2016
March 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Hospitalization for a respiratory-related Illness
Time to first occurrence of hospitalization for a respiratory-related Illness based upon Medicare inpatient hospital claims
up to 1 year
Hospitalization for all causes
Time to first occurrence of hospitalization for all-causes
up to 1 year
Secondary Outcomes (2)
Activities of daily living (ADL) scores
up to 1 year
Mortality
up to 1 year
Other Outcomes (1)
Influenza outbreaks
up to 1 year
Study Arms (2)
aTIV
EXPERIMENTALNH facilities randomized to receive adjuvanted trivalent influenza vaccine (aTIV, FLUAD) for the residents
TIV
ACTIVE COMPARATORNH facilities randomized to receive standard trivalent influenza vaccine (TIV, Fluvirin) for the residents
Interventions
Nursing home residents over 65 years are allocated to receive adjuvanted trivalent vaccine. Residents under 65 years are provided standard trivalent vaccine (TIV-Fluvirin).
Nursing home residents are allocated to receive standard trivalent vaccine (TIV).
Eligibility Criteria
You may qualify if:
- Long-term care facilities within 75 miles of one of the 121 cities that serve as CDC surveillance sites
You may not qualify if:
- Facilities that used high dose influenza vaccine in residents over age 65 in previous influenza season (2015-16)
- Facilities having fewer than 50 long-stay residents
- Hospital-based facilities
- Facilities with more than 20% of the population under age 65
- Facilities not submitting Minimum Data Set (MDS) data
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Insight Therapeutics, LLClead
- Case Western Reserve Universitycollaborator
- Brown Universitycollaborator
- Seqiruscollaborator
Study Sites (1)
Insight Therapeutics, LLC
Norfolk, Virginia, 23510, United States
Related Publications (6)
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.
PMID: 12517228BACKGROUNDThompson 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.
PMID: 15367555BACKGROUNDHayward 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.
PMID: 17142257BACKGROUNDSmith 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.
PMID: 36951196DERIVEDGravenstein 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.
PMID: 33400778DERIVEDMcConeghy 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.
PMID: 32882710DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Gravenstein, MD, MPH
Case Western Reserve Univsity
- PRINCIPAL INVESTIGATOR
Vincent Mor, PhD
Brown University
- PRINCIPAL INVESTIGATOR
H. Edward Davidson, PharmD, MPH
Insight Therapeutics, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2016
First Posted
August 29, 2016
Study Start
April 1, 2016
Primary Completion
October 4, 2018
Study Completion
January 25, 2023
Last Updated
March 15, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share