InfluenzaNCT03599739
Adjuvanted Influenza Vaccination Year 2 Follow-On Survey
An observational study of Influenza and Influenza-like Illness, run by Insight Therapeutics, LLC at 1 site in United States.
Trial summary
The purpose of this study is to determine if different influenza vaccines produce different outcomes in nursing facility residents receiving the required annual influenza vaccination. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Influenza-like Illness, Influenza, Human
- What is being tested?
- Influenza
- Type of treatment
- Vaccines
- How many people
- 598 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2018to 25 Jan 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Older adult
Study population: Long-term care facilities within 75 miles of one of the 121 cities that serve as CDC surveillance sites. These facilities must not have fewer than 50 long-stay residents, facilities that are hospital based, facilities with more than 20% of the population under age 65, and facilities not submitting Minimum Data Set (MDS) data.
Who may be able to join
- Participated in the Adjuvanted Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes study
- OR
- Long-term care facilities within 75 miles of one of the 121 cities that serve as CDC surveillance sites
Who cannot join
- 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: Assessment of Vaccine Selection and Outcomes for the Follow-on Study Year
The purpose of this study is to determine if different influenza vaccines produce different outcomes in nursing facility residents receiving the required annual influenza vaccination.
Read the detailed description
This study will enroll facilities who participated in the adjuvanted influenza vaccine study in 2016-2017 to document the vaccine choice for the 2017-2018 influenza season through a survey. Additional facilities will be enrolled that did not participate to answer a survey responding to questions regarding the vaccine choice for the 2017-2018 and 2018-2019 flu season. Both groups will also gather information on vaccination rates for residents and staff, policies and procedures, and influenza outbreaks.
The facility will complete a profile and answer questions regarding influenza vaccination in their facilities for the 2017-2018 and 2018-2019 flu seasons.
The study team will obtain data from the Centers for Medicare \& Medicaid Services in 2019 to determine the study outcomes. None of the data used in the analysis will be linked to individual residents in facilities.
- Conditions
- Influenza, Influenza-like Illness, Influenza, Human
- Being tested
- Influenza
- Keywords
- Influenza, Vaccine, Vaccination, Nursing Home, Respiratory-Related Hospitalizations
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfluenzaBiological
Facilities will be asked to complete a survey to evaluate the impact of the influenza vaccine choice on hospitalization risk for the 2017-2018 influenza season.
| Study group | Role | What they receive |
|---|---|---|
| Follow-On Cohort | We will survey 823 nursing facilities who participated in the aTIV Influenza Vaccination and Morbitiy and Mortality in U.S. Nursing Homes study in 2016-2017. We anticipate a 70% response rate from this sample for participation. Receives: Biological: Influenza | |
| Parallel Cohort | We will survey an additional 1000 facilities (i.e., facilities not participating in the original 2016-2017 study, but meeting the same entry criteria, except prior use of high dose vaccine will be allowed) in order to capture a cohort that used a wide range of self-selected vaccine choices. We anticipate a 50% response rate from this sample. Receives: Biological: Influenza |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization for all causes
Time to first occurrence of hospitalization for all-causes.
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 posted26 Jul 2018
- Study start13 Jul 2018
- Primary completion15 Feb 2019
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insight Therapeutics, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Seqirus, Brown University
- Responsible party
- Sponsor
- Investigators
- Stefan Gravenstein, MD, MPH, Principal investigator, Brown UniversityVincent Mor, PhD, Principal investigator, Brown UniversityPedro Gozalo, Phd, Principal investigator, Brown UniversityH. Edward Davidson, PharmD, MPH, Principal investigator, Insight Therapeutics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599739
- Sponsor's protocol ID
- INSI-201805
- Status last verified
- Mar 2023
- First submitted
- 16 Jul 2018
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
DiazGranados CA, Dunning AJ, Robertson CA, Talbot HK, Landolfi V, Greenberg DP. Effect of Previous-Year Vaccination on the Efficacy, Immunogenicity, and Safety of High-Dose Inactivated Influenza Vaccine in Older Adults. Clin Infect Dis. 2016 May 1;62(9):1092-1099. doi: 10.1093/cid/ciw085. Epub 2016 Feb 21.
PubMed 26908801Flannery B, Chung JR, Thaker SN, Monto AS, Martin ET, Belongia EA, McLean HQ, Gaglani M, Murthy K, Zimmerman RK, Nowalk MP, Jackson ML, Jackson LA, Foust A, Sessions W, Berman L, Spencer S, Fry AM. Interim Estimates of 2016-17 Seasonal Influenza Vaccine Effectiveness - United States, February 2017. MMWR Morb Mortal Wkly Rep. 2017 Feb 17;66(6):167-171. doi: 10.15585/mmwr.mm6606a3.
PubMed 28207689Gravenstein S, Davidson HE, Taljaard M, Ogarek J, Gozalo P, Han L, Mor V. Comparative effectiveness of high-dose versus standard-dose influenza vaccination on numbers of US nursing home residents admitted to hospital: a cluster-randomised trial. Lancet Respir Med. 2017 Sep;5(9):738-746. doi: 10.1016/S2213-2600(17)30235-7. Epub 2017 Jul 20.
PubMed 28736045
Study at a glance
From the registry record, last updated by the sponsor on 16 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: Assessment of Vaccine Selection and Outcomes for the Follow-on Study Year
- ClinicalTrials.gov ID
- NCT03599739
- Acronym / sponsor ID
- INSI-201805
- Conditions
- Influenza, Influenza-like Illness, Influenza, Human
- Keywords
- Influenza, Vaccine, Vaccination, Nursing Home, Respiratory-Related Hospitalizations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- Insight Therapeutics, LLCUniversity, hospital or other
- Collaborators
- Seqirus, Brown University
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 26 Jul 2018 (actual)
- 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.
The purpose of this study is to determine if different influenza vaccines produce different outcomes in nursing facility residents receiving the required annual influenza vaccination.
Detailed description
This study will enroll facilities who participated in the adjuvanted influenza vaccine study in 2016-2017 to document the vaccine choice for the 2017-2018 influenza season through a survey. Additional facilities will be enrolled that did not participate to answer a survey responding to questions regarding the vaccine choice for the 2017-2018 and 2018-2019 flu season. Both groups will also gather information on vaccination rates for residents and staff, policies and procedures, and influenza outbreaks.
The facility will complete a profile and answer questions regarding influenza vaccination in their facilities for the 2017-2018 and 2018-2019 flu seasons.
The study team will obtain data from the Centers for Medicare \& Medicaid Services in 2019 to determine the study outcomes. None of the data used in the analysis will be linked to individual residents in facilities.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follow-On Cohort | – | Biological: InfluenzaWe will survey 823 nursing facilities who participated in the aTIV Influenza Vaccination and Morbitiy and Mortality in U.S. Nursing Homes study in 2016-2017. We anticipate a 70% response rate from this sample for participation. |
| Parallel Cohort | – | Biological: InfluenzaWe will survey an additional 1000 facilities (i.e., facilities not participating in the original 2016-2017 study, but meeting the same entry criteria, except prior use of high dose vaccine will be allowed) in order to capture a cohort that used a wide range of self-selected vaccine choices. We anticipate a 50% response rate from this sample. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Long-term care facilities within 75 miles of one of the 121 cities that serve as CDC surveillance sites. These facilities must not have fewer than 50 long-stay residents, facilities that are hospital based, facilities with more than 20% of the population under age 65, and facilities not submitting Minimum Data Set (MDS) data.
Key inclusion criteria (3 listed)
- Participated in the Adjuvanted Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes study
- OR
- Long-term care facilities within 75 miles of one of the 121 cities that serve as CDC surveillance sites
Key exclusion criteria (4 listed)
- 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 |
|---|---|---|
| InfluenzaFacilities will be asked to complete a survey to evaluate the impact of the influenza vaccine choice on hospitalization risk for the 2017-2018 influenza season. | Biological | Follow-On Cohort, Parallel Cohort |
Primary outcome
Hospitalization for all causes
Time frame: up to 1 year
Time to first occurrence of hospitalization for all-causes.
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 16 Mar 2023.
- Background: PubMed 26908801DiazGranados CA, Dunning AJ, Robertson CA, Talbot HK, Landolfi V, Greenberg DP. Effect of Previous-Year Vaccination on the Efficacy, Immunogenicity, and Safety of High-Dose Inactivated Influenza Vaccine in Older Adults. Clin Infect Dis. 2016 May 1;62(9):1092-1099. doi: 10.1093/cid/ciw085. Epub 2016 Feb 21.
- Background: PubMed 28207689Flannery B, Chung JR, Thaker SN, Monto AS, Martin ET, Belongia EA, McLean HQ, Gaglani M, Murthy K, Zimmerman RK, Nowalk MP, Jackson ML, Jackson LA, Foust A, Sessions W, Berman L, Spencer S, Fry AM. Interim Estimates of 2016-17 Seasonal Influenza Vaccine Effectiveness - United States, February 2017. MMWR Morb Mortal Wkly Rep. 2017 Feb 17;66(6):167-171. doi: 10.15585/mmwr.mm6606a3.
- Background: PubMed 28736045Gravenstein S, Davidson HE, Taljaard M, Ogarek J, Gozalo P, Han L, Mor V. Comparative effectiveness of high-dose versus standard-dose influenza vaccination on numbers of US nursing home residents admitted to hospital: a cluster-randomised trial. Lancet Respir Med. 2017 Sep;5(9):738-746. doi: 10.1016/S2213-2600(17)30235-7. Epub 2017 Jul 20.
- Australian Influenza Surveillance Report and Activity Updates, Australian Influenza Surveillance Report No. 05 - 08 July to 21 July 2017Link 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
Brown University
Vincent Mor, PhD principal investigator
Brown University
Pedro Gozalo, Phd principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 inclusion and 4 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 16 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.
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 all causes (time frame: up to 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 NCT03599739, which also lists 3 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 16 Mar 2023.