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High Dose Influenza Vaccine in Nursing Home - Pilot Study

NCT01720277 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2957

Last updated 2018-05-23

Study results available
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Summary

The purpose of this pilot evaluation is to help determine the feasibility and power needed to prospectively evaluate relative effectiveness of high-dose influenza vaccine in preventing influenza mortality and hospitalization in a nursing home population in the U.S., compared to the standard-dose influenza vaccine.

Conditions

Interventions

BIOLOGICAL

HD Fluzone Vaccine

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

BIOLOGICAL

SD Fluzone Vaccine

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

Sponsors & Collaborators

  • Brown University

    collaborator OTHER

  • Insight Therapeutics, LLC

    lead OTHER

Principal Investigators

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

  • Ed Davidson, PharmD, MPH · Insight Therapeutics, LLC

  • Vincent Mor, PhD · Brown University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-05-31
Completion
2016-05-31

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 NCT01720277 on ClinicalTrials.gov