InfluenzaPhase 4NCT01720277
High Dose Influenza Vaccine in Nursing Home - Pilot Study
A Phase 4 study testing HD Fluzone Vaccine and SD Fluzone Vaccine in people with Influenza, run by Insight Therapeutics, LLC at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- HD Fluzone Vaccine and SD Fluzone Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,957 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to May 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Long-term care facilities in one of the 122 cities that serve as Center for Disease Control and Prevention (CDC) surveillance sites
Who cannot join
- Facilities already systematically administering HD vaccine to their residents
- Facilities for whom over half the residents are on Medicare (short-stay)
- Facilities in which over half the residents are on Medicare Part A (SNF)
- Facilities having fewer than 50 long-stay residents
- Hospital-based facilities
- Facilities with more than 20% of the population under age 65
- Facilities with mandated (employment-dependent) seasonal influenza vaccination
- Facilities not submitting MDS data
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Insight Therapeutics
Norfolk, Virginia, 23510
Brown Univeristy
Providence, Rhode Island, 02903
About this study
Official title: High Dose Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes - A Pilot Evaluation
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.
Read the detailed description
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.
- Conditions
- Influenza
- Being tested
- HD Fluzone Vaccine, SD Fluzone Vaccine
- Keywords
- Randomized Controlled Trial, Influenza, Influenza vaccine, Flu Vaccine, Fluzone, HD Fluzone, Nursing Homes, Hospitalization, Mortality, Health Care worker vaccination, ADL decline, Pilot, Effectiveness
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD Fluzone VaccineBiological
Also called Fluzone High Dose influenza 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).
SD Fluzone VaccineBiological
Also called Fluzone influenza vaccine
Nursing home residents are allocated to receive standard trivalent vaccine (TIV).
| Study group | Role | What they receive |
|---|---|---|
| HD Fluzone Vaccine | Experimental | NH facilities randomized to receive high dose trivalent influenza vaccine (HD Fluzone) for the residents. Receives: Biological: HD Fluzone Vaccine |
| SD Fluzone Vaccine | Active comparator | NH facilities randomized to standard dose trivalent influenza vaccine (SD Fluzone) for the residents. Receives: Biological: SD Fluzone Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total All-cause Hospitalizations
The primary outcome will establish our methodology for measuring all-cause hospitalizations using the Minimum Data Set (MDS).
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2013
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,957 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insight Therapeutics, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Responsible party
- Principal investigator, Stefan Gravenstein, MD, MPH, Brown University
- Investigators
- Stefan Gravenstein, MD, MPH, Principal investigator, Case Western Reserve UniversityEd Davidson, PharmD, MPH, Principal investigator, Insight Therapeutics, LLCVincent Mor, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720277
- Sponsor's protocol ID
- GRC75-HD Nursing Home Pilot
- Status last verified
- Apr 2018
- First submitted
- 15 Oct 2012
- Last updated
- 23 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 12517228Thompson 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.
PubMed 15367555Hayward 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.
PubMed 17142257Deguchi Y, Nishimura K. Efficacy of Influenza Vaccine in Elderly Persons in Welfare Nursing Homes: Reduction in Risks of Mortality and Morbidity During an Influenza A (H3N2) Epidemic. J Gerontol A Biol Sci Med Sci. 2001 Jun;56(6):M391-4. doi: 10.1093/gerona/56.6.m391.
PubMed 11382801Gozalo PL, Pop-Vicas A, Feng Z, Gravenstein S, Mor V. Effect of influenza on functional decline. J Am Geriatr Soc. 2012 Jul;60(7):1260-7. doi: 10.1111/j.1532-5415.2012.04048.x. Epub 2012 Jun 21.
PubMed 22724499Barker WH, Borisute H, Cox C. A study of the impact of influenza on the functional status of frail older people. Arch Intern Med. 1998 Mar 23;158(6):645-50. doi: 10.1001/archinte.158.6.645.
PubMed 9521230Jackson LA, Jackson ML, Nelson JC, Neuzil KM, Weiss NS. Evidence of bias in estimates of influenza vaccine effectiveness in seniors. Int J Epidemiol. 2006 Apr;35(2):337-44. doi: 10.1093/ije/dyi274. Epub 2005 Dec 20.
PubMed 16368725Simonsen L, Viboud C, Taylor R. Influenza vaccination in elderly people. Lancet. 2005 Dec 17;366(9503):2086. doi: 10.1016/S0140-6736(05)67884-1. No abstract available.
PubMed 16360785Fiore AE, Shay DK, Haber P, Iskander JK, Uyeki TM, Mootrey G, Bresee JS, Cox NJ; Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention and control of influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2007. MMWR Recomm Rep. 2007 Jul 13;56(RR-6):1-54.
PubMed 17625497Kingston BJ, Wright CV Jr. Influenza in the nursing home. Am Fam Physician. 2002 Jan 1;65(1):75-8, 72.
PubMed 11804444Menec VH, Black C, MacWilliam L, Aoki FY. The impact of influenza-associated respiratory illnesses on hospitalizations, physician visits, emergency room visits, and mortality. Can J Public Health. 2003 Jan-Feb;94(1):59-63. doi: 10.1007/BF03405054.
PubMed 12583681Mor V, Intrator O, Unruh MA, Cai S. Temporal and Geographic variation in the validity and internal consistency of the Nursing Home Resident Assessment Minimum Data Set 2.0. BMC Health Serv Res. 2011 Apr 15;11:78. doi: 10.1186/1472-6963-11-78.
PubMed 21496257
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes - A Pilot Evaluation
- ClinicalTrials.gov ID
- NCT01720277
- Acronym / sponsor ID
- GRC75-HD Nursing Home Pilot
- Conditions
- Influenza
- Keywords
- Randomized Controlled Trial, Influenza, Influenza vaccine, Flu Vaccine, Fluzone, HD Fluzone, Nursing Homes, Hospitalization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,957 participants (actual)
- Lead sponsor
- Insight Therapeutics, LLCUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- Sep 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 2 Nov 2012 (estimated)
- Results
- Posted 18 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HD Fluzone Vaccine | Experimental | Biological: HD Fluzone VaccineNH facilities randomized to receive high dose trivalent influenza vaccine (HD Fluzone) for the residents. |
| SD Fluzone Vaccine | Active comparator | Biological: SD Fluzone VaccineNH facilities randomized to standard dose trivalent influenza vaccine (SD Fluzone) for the residents. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Long-term care facilities in one of the 122 cities that serve as Center for Disease Control and Prevention (CDC) surveillance sites
Key exclusion criteria (8 listed)
- Facilities already systematically administering HD vaccine to their residents
- Facilities for whom over half the residents are on Medicare (short-stay)
- Facilities in which over half the residents are on Medicare Part A (SNF)
- Facilities having fewer than 50 long-stay residents
- Hospital-based facilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HD Fluzone VaccineAlso: Fluzone High Dose influenza vaccineNursing home residents over 65 years are allocated to receive high dose trivalent vaccine. Residents under 65 years are provided standard dose trivalent vaccine (TIV). | Biological | HD Fluzone Vaccine |
| SD Fluzone VaccineAlso: Fluzone influenza vaccineNursing home residents are allocated to receive standard trivalent vaccine (TIV). | Biological | SD Fluzone Vaccine |
Primary outcome
Total All-cause Hospitalizations
Time frame: 1 year
The primary outcome will establish our methodology for measuring all-cause hospitalizations using the Minimum Data Set (MDS).
1 secondary outcome
Change in Residents' Functional Status
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12517228Thompson 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: PubMed 15367555Thompson 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: PubMed 17142257Hayward 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.
- Background: PubMed 11382801Deguchi Y, Nishimura K. Efficacy of Influenza Vaccine in Elderly Persons in Welfare Nursing Homes: Reduction in Risks of Mortality and Morbidity During an Influenza A (H3N2) Epidemic. J Gerontol A Biol Sci Med Sci. 2001 Jun;56(6):M391-4. doi: 10.1093/gerona/56.6.m391.
- Background: PubMed 22724499Gozalo PL, Pop-Vicas A, Feng Z, Gravenstein S, Mor V. Effect of influenza on functional decline. J Am Geriatr Soc. 2012 Jul;60(7):1260-7. doi: 10.1111/j.1532-5415.2012.04048.x. Epub 2012 Jun 21.
- Background: PubMed 9521230Barker WH, Borisute H, Cox C. A study of the impact of influenza on the functional status of frail older people. Arch Intern Med. 1998 Mar 23;158(6):645-50. doi: 10.1001/archinte.158.6.645.
- Background: PubMed 16368725Jackson LA, Jackson ML, Nelson JC, Neuzil KM, Weiss NS. Evidence of bias in estimates of influenza vaccine effectiveness in seniors. Int J Epidemiol. 2006 Apr;35(2):337-44. doi: 10.1093/ije/dyi274. Epub 2005 Dec 20.
- Background: PubMed 16360785Simonsen L, Viboud C, Taylor R. Influenza vaccination in elderly people. Lancet. 2005 Dec 17;366(9503):2086. doi: 10.1016/S0140-6736(05)67884-1. No abstract available.
- Background: PubMed 17625497Fiore AE, Shay DK, Haber P, Iskander JK, Uyeki TM, Mootrey G, Bresee JS, Cox NJ; Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention and control of influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2007. MMWR Recomm Rep. 2007 Jul 13;56(RR-6):1-54.
- Background: PubMed 11804444Kingston BJ, Wright CV Jr. Influenza in the nursing home. Am Fam Physician. 2002 Jan 1;65(1):75-8, 72.
- Background: PubMed 12583681Menec VH, Black C, MacWilliam L, Aoki FY. The impact of influenza-associated respiratory illnesses on hospitalizations, physician visits, emergency room visits, and mortality. Can J Public Health. 2003 Jan-Feb;94(1):59-63. doi: 10.1007/BF03405054.
- Background: PubMed 21496257Mor V, Intrator O, Unruh MA, Cai S. Temporal and Geographic variation in the validity and internal consistency of the Nursing Home Resident Assessment Minimum Data Set 2.0. BMC Health Serv Res. 2011 Apr 15;11:78. doi: 10.1186/1472-6963-11-78.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Gravenstein, MD, MPH principal investigator
Case Western Reserve University
Ed Davidson, PharmD, MPH principal investigator
Insight Therapeutics, LLC
Vincent Mor, PhD principal investigator
Brown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HD Fluzone Vaccine and SD Fluzone Vaccine in people with Influenza, run by Insight Therapeutics, LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total All-cause Hospitalizations (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01720277, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2018.