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

NCT03694808 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2024-04-30

Study results available
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Summary

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

Conditions

Interventions

DRUG

Fluad Vaccine

single adjuvanted dose (AD) intramuscular injection

DRUG

Fluzone HD Vaccine

single high dose (HD) intramuscular injection

Sponsors & Collaborators

  • Case Western Reserve University

    collaborator OTHER

  • US Department of Veterans Affairs

    collaborator FED

  • Brown University

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • David H. Canaday

    lead OTHER

Principal Investigators

  • David Canaday, MD · University Hospitals Cleveland Medical Center/Case Western Reserve University/Louis Stokes Cleveland VA Medical Center

  • Steven Gravenstein, MD, MPH · Brown University and Providence VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-23
Primary Completion
2023-01-31
Completion
2023-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03694808 on ClinicalTrials.gov