FLUAD vs. FLUZONE HD Influenza Vaccine in Residents of Long Term Care

NCT03694808 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 10-27-291R01AI129709-01A1
• Study Type: interventional
• Target: 478
• Locations: 1 country
• Sites: 2

Brief Summary

Adjuvanted flu vaccine, Fluad, is not immunologically inferior to HD influenza vaccine in older persons living in long-term care.

Conditions

Flu

Keywords

Flu; Vaccine

Outcome Measures

Primary Outcomes (6)

• Overall Hemagglutinin Inhibition (HAI) H1N1 Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.

  HAI is an in vitro bioassay testing subjects' sera for specific anti-influenza antibodies to each strain in the vaccine. Seroconversion is 4-fold rise in antibody titer. The FDA uses this as the standard immunogenicity assay for licensure. The investigators will follow the guidelines set out in the FDA guidance document on non-inferiority immunogenicity studies for the analysis plan.

  1 month post vaccine administration

• Overall Hemagglutinin Inhibition (HAI) H3N2 Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.

  HAI is an in vitro bioassay testing subjects' sera for specific anti-influenza antibodies to each strain in the vaccine. Seroconversion is 4-fold rise in antibody titer. The FDA uses this as the standard immunogenicity assay for licensure. The investigators will follow the guidelines set out in the FDA guidance document on non-inferiority immunogenicity studies for the analysis plan.

  1 month post vaccine administration

• Overall Hemagglutinin Inhibition (HAI) B Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.

  HAI is an in vitro bioassay testing subjects' sera for specific anti-influenza antibodies to each strain in the vaccine. Seroconversion is 4-fold rise in antibody titer. The FDA uses this as the standard immunogenicity assay for licensure. The investigators will follow the guidelines set out in the FDA guidance document on non-inferiority immunogenicity studies for the analysis plan.

  1 month post vaccine administration

• Overall HAI H1N1 Seroconversion Rate Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.

  HAI is an in vitro bioassay testing subjects' sera for specific anti-influenza antibodies to each strain in the vaccine. Seroconversion is 4-fold rise in antibody titer. The FDA uses this as the standard immunogenicity assay for licensure. The investigators will follow the guidelines set out in the FDA guidance document on non-inferiority immunogenicity studies for the analysis plan.

  1 month post vaccine administration

• Overall HAI H3N2 Seroconversion Rate Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.

  HAI is an in vitro bioassay testing subjects' sera for specific anti-influenza antibodies to each strain in the vaccine. Seroconversion is 4-fold rise in antibody titer. The FDA uses this as the standard immunogenicity assay for licensure. The investigators will follow the guidelines set out in the FDA guidance document on non-inferiority immunogenicity studies for the analysis plan.

  1 month post vaccine administration

• Overall HAI B Seroconversion Rate Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.

  HAI is an in vitro bioassay testing subjects' sera for specific anti-influenza antibodies to each strain in the vaccine. Seroconversion is 4-fold rise in antibody titer. The FDA uses this as the standard immunogenicity assay for licensure. The investigators will follow the guidelines set out in the FDA guidance document on non-inferiority immunogenicity studies for the analysis plan.

  1 month post vaccine administration

Secondary Outcomes (9)

• Overall Neuraminidase Inhibition (NAI) H1N1 Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.

  1 month post vaccine administration

• Overall Neuraminidase Inhibition (NAI) H3N2 Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.

  1 month post vaccine administration

• Overall H1N1 NAI Seroconversion Rate Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.

  1 month post vaccine administration

• Overall NAI H3N2 Seroconversion Rate Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.

  1 month post vaccine administration

• Overall Serum Virus Neutralization (SVN) H1N1 Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.

  1 month post vaccine administration

Other Outcomes (1)

• To Pilot Clinical Objective: Efficacy of FLUAD Will be Compared to FLUZONE HD.

  6-8 months post vaccine administration

Study Arms (2)

Fluad Vaccine

ACTIVE COMPARATOR

A single adjuvanted dose (AD) intramuscular injection

Drug: Fluad Vaccine

Fluzone Vaccine

ACTIVE COMPARATOR

A single high dose (HD) intramuscular injection

Drug: Fluzone HD Vaccine

Interventions

Fluad Vaccine DRUG

single adjuvanted dose (AD) intramuscular injection

Fluad Vaccine

Fluzone HD Vaccine DRUG

single high dose (HD) intramuscular injection

Fluzone Vaccine

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \> 65 years old
• Able to obtain consent from subject or legally authorized representative (subject to provide assent if cognitively/physically able to do so)
• Able to participate throughout the study period

You may not qualify if:

• Recent illness (within 30 days) severe enough to require hospitalization or physician-directed outpatient pharmacotherapy
• Administration of immunomodulatory agents (e.g. oral corticosteroids except prednisone \< 10 mg daily, cyclosporine, and biologics (DMARDS) for Rheumatologic/Dermatologic conditions) in the last 3 months
• Cancer requiring treatment in the past three years, except for non- melanoma skin cancers or cancers that have clearly been cured or carry an excellent prognosis including prostate cancer.
• Myocardial infarction, major heart surgery (i.e. valve replacement or bypass surgery), stroke, deep vein thrombosis or pulmonary embolus in the past 4 months
• Allergies or history of significant adverse reactions to any component of influenza vaccine including egg protein and latex or after a previous dose of any influenza vaccine.
• History of Guillian-Barré Syndrome within 6 weeks of a prior influenza vaccine.

Sponsors & Collaborators

• David H. Canaday: lead
• Case Western Reserve University: collaborator
• US Department of Veterans Affairs: collaborator
• Brown University: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (2)

Louis Stokes Cleveland VA Medical Center

Cleveland, Ohio, 44106, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (19)

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  BACKGROUND

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  PMID: 40373825 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

fluad vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Limitations and Caveats

1. For all SVN related outcomes (11, 13, 14, 15) data was only collected for the 2018-2019 season 2. \>38% of values are at upper limit of detection (25% of Day 0 and \>50% of Day 28 values) Thus, the assay fails to capture any variability in values \> 1000. Given how many subjects have values in this range, we are unable to accurately summarize group differences; and a seroconversion endpoint that requires measuring change from d0 to d28 cannot be validly measured given this limitation.

Results Point of Contact

• Title: Dr. David Canaday
• Organization: University Hospitals Cleveland Medical Center

dxc44@case.edu

216-368-5537

Study Officials

• David Canaday, MD

  University Hospitals Cleveland Medical Center/Case Western Reserve University/Louis Stokes Cleveland VA Medical Center

  PRINCIPAL INVESTIGATOR

• Steven Gravenstein, MD, MPH

  Brown University and Providence VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine at Case Western Reserve University and Associate Director, Geriatric, Research, Education and Clinical Center at Louis Stokes Cleveland VA Medical Center

Model Details: A non-inferiority randomized clinical trial to enroll 500 long term care (LTC) dwellers from at least one of 40 nursing homes sites in northern Ohio. Age 65 and older to receive either Fluad or HD vaccine at 1:1 ratio. Blood will be sampled pre- and post-vaccine and post-influenza season and coded for blinded laboratory analysis. Randomization by from randomizer.org software./RedCAP

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 3, 2018
• Study Start: September 23, 2018
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: April 30, 2024
• Results First Posted: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)