InfluenzaPhase 4NCT02882100
Adjuvanted Influenza Vaccination in U.S. Nursing Homes
A Phase 4 study testing adjuvanted trivalent influenza vaccine and trivalent influenza vaccine in people with Influenza and Influenza-like Illness, run by Insight Therapeutics, LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Influenza, Influenza-like Illness
- What is being tested?
- adjuvanted trivalent influenza vaccine and trivalent influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 823 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 25 Jan 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 within 75 miles of one of the 121 cities that serve as CDC surveillance sites
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjuvanted Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes
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).
Read the detailed description
SUMMARY: A random study sample of up to 1000 NHs within 75 miles of the local area of the 121 cities where the CDC performs weekly influenza surveillance (estimated N= 11,239) may be offered the opportunity for participation; the first 1000 eligible to participate and accepting the offer will be enrolled. Participating facilities will be offered vaccine education for residents and staff, but will be randomly allocated to receive aTIV (FLUAD) vaccine or usual care (TIV) vaccination for their residents.
BACKGROUND: Lower respiratory tract infection (LRI), including pneumonia, bronchitis, and tracheobronchitis, is the leading cause of infectious mortality and hospitalization in older adults , and nursing home (NH) residents. Pneumonia and infection often produce attenuated signs and symptoms in older adults, leading to delayed or even misdiagnosis for this population. Diagnosis is further compromised due to few and sporadic clinician visits with nursing home residents, and reduced access to radiology. LRI may or may not directly lead to hospitalization, but LRIs are associated with considerable other morbidity than can result in hospitalization, including exacerbation of underlying cardiopulmonary diseases. Hospitalization rates for NH residents vary considerably between facilities, but the majority of hospitalizations occur during the 12 weeks during which influenza peaks each year.
OBJECTIVES: The primary objective is to estimate the differences in hospitalization rates during influenza season experienced by long-stay nursing home residents, between facilities using adjuvanted trivalent vaccine vs. standard trivalent vaccine. The secondary objective is to estimate the differences in the likelihood of Activities of Daily Living (ADL) functional decline and mortality rates in the study nursing homes, and influenza outbreaks.
- Conditions
- Influenza, Influenza-like Illness
- Being tested
- adjuvanted trivalent influenza vaccine, trivalent influenza vaccine
- Keywords
- influenza, vaccine, vaccination, nursing home, cluster randomized trial, respiratory-related hospitalization
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjuvanted trivalent influenza vaccineBiological
Also called Fluad, aTIV
Nursing home residents over 65 years are allocated to receive adjuvanted trivalent vaccine. Residents under 65 years are provided standard trivalent vaccine (TIV-Fluvirin).
trivalent influenza vaccineBiological
Also called Fluvirin, TIV
Nursing home residents are allocated to receive standard trivalent vaccine (TIV).
| Study group | Role | What they receive |
|---|---|---|
| aTIV | Experimental | NH facilities randomized to receive adjuvanted trivalent influenza vaccine (aTIV, FLUAD) for the residents Receives: Biological: adjuvanted trivalent influenza vaccine; Biological: trivalent influenza vaccine |
| TIV | Active comparator | NH facilities randomized to receive standard trivalent influenza vaccine (TIV, Fluvirin) for the residents Receives: Biological: trivalent influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization for a respiratory-related Illness
Time to first occurrence of hospitalization for a respiratory-related Illness based upon Medicare inpatient hospital claims
Measured: up to 1 year
Hospitalization for all causes
Time to first occurrence of hospitalization for all-causes
Measured: up to 1 year
Secondary outcomes (2)
Activities of daily living (ADL) scores
Change in activities of daily living (ADL) scores
Measured: up to 1 year
Mortality
Difference in mortality rate
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startApr 2016
- Primary completion4 Oct 2018
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- 823 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insight Therapeutics, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, Brown University, Seqirus
- Responsible party
- Sponsor
- Investigators
- Stefan Gravenstein, MD, MPH, Principal investigator, Case Western Reserve UnivsityVincent Mor, PhD, Principal investigator, Brown UniversityH. Edward Davidson, PharmD, MPH, Principal investigator, Insight Therapeutics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882100
- Sponsor's protocol ID
- INSI-201603
- Status last verified
- Mar 2023
- First submitted
- 24 Aug 2016
- Last updated
- 15 Mar 2023
- Results posted
- No
- 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 17142257Smith 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.
PubMed 36951196Gravenstein 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.
PubMed 33400778McConeghy 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.
PubMed 32882710
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvanted Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes
- ClinicalTrials.gov ID
- NCT02882100
- Acronym / sponsor ID
- INSI-201603
- Conditions
- Influenza, Influenza-like Illness
- Keywords
- influenza, vaccine, vaccination, nursing home, cluster randomized trial, respiratory-related hospitalization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 823 participants (actual)
- Lead sponsor
- Insight Therapeutics, LLCUniversity, hospital or other
- Collaborators
- Case Western Reserve University, Brown University, Seqirus
- Study start
- Apr 2016 (actual)
- Primary completion
- 4 Oct 2018 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
SUMMARY: A random study sample of up to 1000 NHs within 75 miles of the local area of the 121 cities where the CDC performs weekly influenza surveillance (estimated N= 11,239) may be offered the opportunity for participation; the first 1000 eligible to participate and accepting the offer will be enrolled. Participating facilities will be offered vaccine education for residents and staff, but will be randomly allocated to receive aTIV (FLUAD) vaccine or usual care (TIV) vaccination for their residents.
BACKGROUND: Lower respiratory tract infection (LRI), including pneumonia, bronchitis, and tracheobronchitis, is the leading cause of infectious mortality and hospitalization in older adults , and nursing home (NH) residents. Pneumonia and infection often produce attenuated signs and symptoms in older adults, leading to delayed or even misdiagnosis for this population. Diagnosis is further compromised due to few and sporadic clinician visits with nursing home residents, and reduced access to radiology. LRI may or may not directly lead to hospitalization, but LRIs are associated with considerable other morbidity than can result in hospitalization, including exacerbation of underlying cardiopulmonary diseases. Hospitalization rates for NH residents vary considerably between facilities, but the majority of hospitalizations occur during the 12 weeks during which influenza peaks each year.
OBJECTIVES: The primary objective is to estimate the differences in hospitalization rates during influenza season experienced by long-stay nursing home residents, between facilities using adjuvanted trivalent vaccine vs. standard trivalent vaccine. The secondary objective is to estimate the differences in the likelihood of Activities of Daily Living (ADL) functional decline and mortality rates in the study nursing homes, and influenza outbreaks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aTIV | Experimental | Biological: adjuvanted trivalent influenza vaccine, Biological: trivalent influenza vaccineNH facilities randomized to receive adjuvanted trivalent influenza vaccine (aTIV, FLUAD) for the residents |
| TIV | Active comparator | Biological: trivalent influenza vaccineNH facilities randomized to receive standard trivalent influenza vaccine (TIV, Fluvirin) 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 within 75 miles of one of the 121 cities that serve as CDC surveillance sites
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| adjuvanted trivalent influenza vaccineAlso: Fluad, aTIVNursing home residents over 65 years are allocated to receive adjuvanted trivalent vaccine. Residents under 65 years are provided standard trivalent vaccine (TIV-Fluvirin). | Biological | aTIV |
| trivalent influenza vaccineAlso: Fluvirin, TIVNursing home residents are allocated to receive standard trivalent vaccine (TIV). | Biological | TIV, aTIV |
Primary outcome
Hospitalization for a respiratory-related Illness
Time frame: up to 1 year
Time to first occurrence of hospitalization for a respiratory-related Illness based upon Medicare inpatient hospital claims
Hospitalization for all causes
Time frame: up to 1 year
Time to first occurrence of hospitalization for all-causes
2 secondary outcomes
Activities of daily living (ADL) scores
Time frame: up to 1 year
Mortality
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- 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.
- Derived from this study: PubMed 36951196Smith 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.
- Derived from this study: PubMed 33400778Gravenstein 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.
- Derived from this study: PubMed 32882710McConeghy 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.
- FDA approves first seasonal influenza vaccine containing an adjuvantLink provided by the sponsor.
- 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 Univsity
Vincent Mor, PhD principal investigator
Brown University
H. Edward Davidson, PharmD, MPH principal investigator
Insight Therapeutics, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing adjuvanted trivalent influenza vaccine and trivalent influenza vaccine in people with Influenza and Influenza-like Illness, run by Insight Therapeutics, LLC at 1 site 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 5 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 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hospitalization for a respiratory-related Illness (time frame: up to 1 year). The study lists 2 primary outcomes in all. 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 NCT02882100, which also lists 6 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 15 Mar 2023.