A Phase 4 interventional study of HD Fluzone Vaccine and SD Fluzone Vaccine in Influenza, sponsored by Insight Therapeutics, LLC. Completed at 2 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2018-05-23.
Sponsored by Insight Therapeutics, LLC · Phase 4, Interventional, and Prevention
The purpose of this pilot evaluation is to help determine the feasibility and power needed to prospectively evaluate relative effectiveness of high-dose influenza vaccine in preventing influenza mortality and hospitalization in a nursing home population in the U.S., compared to the standard-dose influenza vaccine.
Influenza remains the most common preventable respiratory viral infection of older adults. Older adults incur more than 90% of the disease burden, and those residing in nursing homes are the most affected subset given their immune senescence, multi-morbidity, and close living quarters. Each year, the majority of influenza-related hospitalizations occur during the period with the greatest influenza activity.
Influenza vaccination has been associated with reduced hospitalization, strokes, heart attacks and death in non-institutional older adult populations, but the benefit of influenza vaccine for the oldest population has been questioned. The new high-dose influenza vaccine is considerably more immunogenic in older adults, and has recently been approved for use in individuals aged 65 years and older. No clinical data yet confirm whether the improved immunogenicity translates into added clinical benefit, such as further reduction in hospitalization or death. Estimating the benefit of influenza vaccination among older adults in long-term care settings using randomized controlled trials requires extensive effort and is costly. Instead, a pragmatic RCT in a nursing home population has several advantages as a model for comparing therapeutic approaches.
This clinical trial aims to test the feasibility of our protocol for a subsequent larger study. We aim to demonstrate that we can recruit and enroll facilities; randomly assign and coordinate vaccine delivery; collect data; conduct site audits for data validation; create outcomes using multiple data sources; and conduct analyses.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 2,957 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Insight Therapeutics, LLC is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
NH facilities randomized to receive high dose trivalent influenza vaccine (HD Fluzone) for the residents.
Biological: HD Fluzone Vaccine
NH facilities randomized to standard dose trivalent influenza vaccine (SD Fluzone) for the residents.
Biological: SD Fluzone Vaccine
Nursing home residents over 65 years are allocated to receive high dose trivalent vaccine. Residents under 65 years are provided standard dose trivalent vaccine (TIV).
Also known as: Fluzone High Dose influenza vaccine
Nursing home residents are allocated to receive standard trivalent vaccine (TIV).
Also known as: Fluzone influenza vaccine
Total All-cause Hospitalizations
The primary outcome will establish our methodology for measuring all-cause hospitalizations using the Minimum Data Set (MDS).
Time frame: 1 year
Change in Residents' Functional Status
The secondary outcome will establish our methodology for measuring change in functional status of nursing home residents using Activities of Daily Living (ADL) data in the Minimum Data Set (MDS). A change in functional status is defined as a decline in physical functioning by at least 4 points on the 28-point ADL scale.
Time frame: 1 year
Recruit, Enroll, and Randomize Nursing Homes Per Calculated Sample Size
This outcome evaluates our ability to recruit and enroll nursing facilities that meet our inclusion and exclusion criteria, and ensure nursing home residents receive either high-dose or standard-dose influenza vaccine
Time frame: 1 year
Cluster--We included nursing homes (NHs) within 50 miles of a CDC surveillance. We identified and contacted individual facilities and organizations. Each recruited NH completed a site feasibility form and was notified of its eligibility based on the exclusion criteria. Subject--Eligible nursing home residents in each participating facility.
| Milestone | High-Dose Vaccine for Residents | Standard-dose for Residents |
|---|---|---|
| Started | 1461 | 1496 |
| Completed | 958 | 938 |
| Not completed | 503 | 558 |
The primary outcome will establish our methodology for measuring all-cause hospitalizations using the Minimum Data Set (MDS).
| events | High-Dose Vaccine for Residents | Standard-dose for Residents |
|---|---|---|
| Total All-cause Hospitalizations | 197 | 301 |
The secondary outcome will establish our methodology for measuring change in functional status of nursing home residents using Activities of Daily Living (ADL) data in the Minimum Data Set (MDS). A change in functional status is defined as a decline in physical functioning by at least 4 points on the 28-point ADL scale.
| Participants | HD Fluzone Vaccine | SD Fluzone Vaccine |
|---|---|---|
| Change in Residents' Functional Status | 196 | 206 |
This outcome evaluates our ability to recruit and enroll nursing facilities that meet our inclusion and exclusion criteria, and ensure nursing home residents receive either high-dose or standard-dose influenza vaccine
| Nursing Homes | HD Fluzone Vaccine | SD Fluzone Vaccine |
|---|---|---|
| Recruit, Enroll, and Randomize Nursing Homes Per Calculated Sample Size | 20 | 19 |
Collected over The study did not collect adverse events.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High-Dose Vaccine for Residents | 249/1,461 (17%) | — | — |
| Standard-dose for Residents | 274/1,496 (18.3%) | — | — |
Characteristics of participating facilities that met our inclusion criteria and were randomized. Residents in each participating facility were offered influenza vaccine according to the randomization.
| Age, Customized(years) | High-Dose Vaccine for Residents | Standard-dose for Residents | Total |
|---|---|---|---|
| Average age | 84.5 ± 8.4 | 83.4 ± 8.7 | 84.0 ± 8.6 |
| Sex/Gender, Customized(Participants) | High-Dose Vaccine for Residents | Standard-dose for Residents | Total |
|---|---|---|---|
| Percent of female nursing home residents | 1094 | 1113 | 2207 |
| Number of residents per nursing home(participants) | High-Dose Vaccine for Residents | Standard-dose for Residents | Total |
|---|---|---|---|
| Mean | 108 ± 49 | 124 ± 54 | 116 ± 51 |
| Percent of residents who are long-stay(percent) | High-Dose Vaccine for Residents | Standard-dose for Residents | Total |
|---|---|---|---|
| Mean | 88.0 ± 6.5 | 86.5 ± 12.1 | 87.2 ± 9.7 |
| Number of long-stay residents who are over 65 years of age(participants) | High-Dose Vaccine for Residents | Standard-dose for Residents | Total |
|---|---|---|---|
| Mean | 78 ± 37 | 78 ± 44 | 78 ± 40 |
| Percent of residents with Medicaid as payer(percent) | High-Dose Vaccine for Residents | Standard-dose for Residents | Total |
|---|---|---|---|
| Mean | 62.5 ± 12.8 | 62.9 ± 17.4 | 62.7 ± 15.0 |
| Percent of residents in for-profit nursing facilities(percent) | High-Dose Vaccine for Residents | Standard-dose for Residents | Total |
|---|---|---|---|
| Mean | 70.0 ± 47.0 | 73.6 ± 45.2 | 71.8 ± 45.6 |
| Number of nursing facilities that are part of a chain(nursing homes) | High-Dose Vaccine for Residents | Standard-dose for Residents | Total |
|---|---|---|---|
| Number | 10 | 6 | 16 |
Plan to share: No
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Insight Therapeutics, LLC