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Adjuvanted Influenza Vaccination in U.S. Nursing Homes

NCT02882100 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 823

Last updated 2023-03-15

No results posted yet for this study

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 seasonal influenza vaccine (TIV; Fluvirin).

Conditions

Interventions

BIOLOGICAL

adjuvanted trivalent influenza vaccine

Nursing home residents over 65 years are allocated to receive adjuvanted trivalent vaccine. Residents under 65 years are provided standard trivalent vaccine (TIV-Fluvirin).

BIOLOGICAL

trivalent influenza vaccine

Nursing home residents are allocated to receive standard trivalent vaccine (TIV).

Sponsors & Collaborators

  • Case Western Reserve University

    collaborator OTHER

  • Brown University

    collaborator OTHER

  • Seqirus

    collaborator INDUSTRY

  • Insight Therapeutics, LLC

    lead OTHER

Principal Investigators

  • Stefan Gravenstein, MD, MPH · Case Western Reserve Univsity

  • Vincent Mor, PhD · Brown University

  • H. Edward Davidson, PharmD, MPH · Insight Therapeutics, LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-10-04
Completion
2023-01-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02882100 on ClinicalTrials.gov