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InfluenzaPhase 4NCT03965195

Recombinant Influenza Vaccination in U.S. Nursing Homes

A Phase 4 study testing Recombinant Influenza Vaccine and Standard Dose Quadrivalent Influenza Vaccine in people with Influenza and Influenza -Like Illness, run by Insight Therapeutics, LLC at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Based on recent evidence on the mutation of the A/H3N2 strain in egg-grown vaccine, the investigators will study the quadrivalent recombinant influenza vaccine (RIV4, Flublok) compared to the standard dose quadrivalent vaccine (IV4) in a cohort of long-stay NH residents with a primary endpoint of all-cause… Read more about this study

Who is it for?
Ages 18 to 120 yearsHealthy volunteers can take part
What is being tested?
Recombinant Influenza Vaccine and Standard Dose Quadrivalent Influenza Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,989 participants
Where
1 siteUnited States
Study dates
20 Jul 2019to Dec 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 18 to 120 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Medicare-certified NHs with at least 50 long-stay residents ≥ 18 years of age
  • Facilities with at least 80% of their long-stay population ≥ 65 years of age or at least 70 long stay residents ≥ 65 years of age that make up ≥ 45% of their total number of beds

Who cannot join

  • Hospital-based facilities
  • Facilities where Fluzone High-Dose or Fluad was used in the previous influenza season (2018-19 or 2019-20), or who's leadership plans to use one of these vaccines in the 2019- 2020 or 2020-21 season
  • Facilities not submitting MDS data
  • Facilities not in one of the 50 U.S. states

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Insight Therapeutics, LLC

    Norfolk, Virginia, 23510

Other trials in United States

About this study

Official title: Comparative Effectiveness of Recombinant Versus Standard Dose Quadrivalent Influenza Vaccine in U.S. Nursing Homes

Based on recent evidence on the mutation of the A/H3N2 strain in egg-grown vaccine, the investigators will study the quadrivalent recombinant influenza vaccine (RIV4, Flublok) compared to the standard dose quadrivalent vaccine (IV4) in a cohort of long-stay NH residents with a primary endpoint of all-cause hospitalization.

Read the detailed description

A study sample goal of 1000 U.S. NHs, housing approximately 112,000 overall residents and 92,000 over the age of 65 years, of whom 64,500 are long-stay NH residents, will be recruited for each of the 2019-20 and 2020-21 influenza seasons. Participating facilities will be randomly allocated in a 1:1 ratio to RIV4 or IV4 vaccine for their residents. Also, all staff must be offered the same vaccine in both allocation groups, in order to eliminate differences in transmission of influenza through staff to residents related to differences in vaccine-related protection of staff and will reduce heterogeneity between clusters. The Minimum Data Set from the NH resident assessment instrument will be evaluated from all evaluable facilities meeting inclusion criteria and will be cross-referenced to Medicare claims and drug use data.

Being tested
Recombinant Influenza Vaccine, Standard Dose Quadrivalent Influenza Vaccine
Keywords
Influenza, Vaccine, Vaccination, Nursing Home, Respiratory-Related Hospitalizations, Cluster Randomized Trial, MACE (Major Adverse Cardiovascular Event), Cardiorespiratory-Related Hospitalizations, All-Cause 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.

  • Recombinant Influenza VaccineBiological

    Also called Flublok, RIV4

    Nursing home residents and staff 18 years and older are allocated to receive quadrivalent recombinant influenza vaccine.

  • Standard Dose Quadrivalent Influenza VaccineBiological

    Also called IV4

    Nursing home residents and staff 18 years and older are allocated to receive standard dose quadrivalent influenza vaccine

Study groups in NCT03965195
Study groupRoleWhat they receive
RIV4ExperimentalNursing homes randomized to receive quadrivalent recombinant influenza vaccine (Flublok) for the residents and staff
Receives: Biological: Recombinant Influenza Vaccine
IV4Active comparatorNursing homes randomized to receive standard dose quadrivalent influenza vaccine for the residents and staff
Receives: Biological: Standard Dose Quadrivalent Influenza Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differences in all-cause hospitalization rates during the 2019-20 and 2020-21 influenza seasons

    To determine the differences in all-cause hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by all long-stay nursing home residents 18 years of age and older in facilities randomized to offer either quadrivalent recombinant influenza vaccine (RIV4) or standard dose quadrivalent influenza vaccine (IV4).

    Measured: Up to 8 months each influenza season

Secondary outcomes (9)

  1. Differences in each pneumonia and influenza-related hospitalization rates

    To determine the differences in each pneumonia and influenza-related hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by long-stay nursing home residents in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.

    Measured: Up to 8 months each influenza season

  2. Differences in pneumonia-related hospitalization rates

    To determine the differences in each pneumonia-related hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by long-stay nursing home residents in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.

    Measured: Up to 8 months each influenza season

  3. Differences in major adverse cardiovascular event-related (MACE) hospitalization rates

    To determine the differences in each major adverse cardiovascular event-related (MACE) hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by long-stay nursing home residents in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.

    Measured: Up to 8 months each influenza season

  4. Differences in cardiorespiratory-related hospitalization rates

    To determine the differences in long-stay residents' cardiorespiratory-related hospitalization rates each season and across two seasons in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.

    Measured: Up to 8 months each influenza season

  5. Differences in ICU stay

    To determine the differences in long-stay residents' ICU stay each season and across two seasons in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.

    Measured: Up to 8 months each influenza season

  6. Differences in mortality rates

    To determine the differences in long-stay residents' mortality rates each influenza season and both seasons in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.

    Measured: Up to 8 months each influenza season

  7. Differences in activities of daily living (ADL) function score

    To determine the differences in long-stay residents' composite Activities of Daily Living (ADL) function score based on the MDS experienced during the influenza season by selected comorbidities and specific to respiratory illness, in facilities randomized to either RIV4 or IV4 combined over two seasons for each, residents 18 years of age and older and those 65 years of age and older.

    Measured: Up to 8 months each influenza season

  8. Differences in facility-reported outbreaks

    To determine differences in facility-reported outbreaks each season and across two seasons in facilities randomized to either RIV4 or IV4

    Measured: Up to 8 months each influenza season

  9. Differences in all-cause hospitalization rates

    To determine differences in long-stay residents' all-cause hospitalization rates as an interim exploratory analysis based on the Minimum Data Set 3.0 for each, residents 18 years of age and older and those 65 years of age and older.

    Measured: Up to 8 months each influenza season

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2019
  2. Study start20 Jul 2019
  3. Primary completionAug 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

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
None (open label)
Enrolment
1,989 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03965195
Sponsor's protocol ID
INSI-201902
Status last verified
Mar 2023
First submitted
20 May 2019
Last updated
15 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • McConeghy KW, Davidson HE, Canaday DH, Han L, Hayes K, Baier RR, Abul Y, Saade E, Mor V, Gravenstein S. Recombinant vs Egg-Based Quadrivalent Influenza Vaccination for Nursing Home Residents: A Cluster Randomized Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2452677. doi: 10.1001/jamanetworkopen.2024.52677.

    PubMed 39745702

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Recombinant Influenza Vaccine and Standard Dose Quadrivalent 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 2 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: status not confirmed, 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?

Results are not available in the source record.

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?

Differences in all-cause hospitalization rates during the 2019-20 and 2020-21 influenza seasons (time frame: Up to 8 months each influenza season). 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 NCT03965195, which also lists 1 linked publication.

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.

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