MedTrace Logo

High-Dose Influenza Vaccine in Nursing Homes

NCT01815268 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 823

Last updated 2018-07-16

No results posted yet for this study

Summary

The purpose of this study is to prospectively evaluate relative effectiveness of high dose influenza vaccine in preventing influenza mortality, hospitalization, and functional decline in a nursing home population in the U.S., compared to the standard dose trivalent seasonal influenza vaccine.

Conditions

Interventions

BIOLOGICAL

HD Vaccine

Nursing home residents over 65 years are allocated to receive high-dose vaccine. Residents under 65 years are provided standard-dose vaccine.

BIOLOGICAL

SD Vaccine

Nursing home residents are allocated to receive standard-dose vaccine.

BIOLOGICAL

Free Vaccine

Nursing home facilities are provided free standard-dose vaccine for their staff.

BIOLOGICAL

Usual Care

Nursing home staff will have access to influenza vaccine, per standard of care. No free vaccine provided as part of study.

Sponsors & Collaborators

  • Brown University

    collaborator OTHER

  • Case Western Reserve University

    collaborator OTHER

  • Insight Therapeutics, LLC

    lead OTHER

Principal Investigators

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

  • Vincent Mor, PhD · Brown University

  • Ed 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
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2017-05-15
Completion
2018-09-30

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 NCT01815268 on ClinicalTrials.gov