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Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting

NCT01654224 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2017-07-02

Study results available
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Summary

The purpose of the study is to compare the performance of two currently available influenza (flu) vaccines. This study will try and determine if the high dose flu vaccine provides protection that is the same or better than that of regular dose flu vaccine. Both the regular dose and the high dose flu vaccines are approved by the FDA for use in older adults.

Conditions

Interventions

BIOLOGICAL

High Dose Inactivated Influenza Vaccine

0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin

BIOLOGICAL

Standard Dose Inactivated Influenza Vaccine

0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    collaborator INDUSTRY

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • David A. Nace, MD, MPH, CMD · University of Pittsburgh, Division of Geriatric Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-06-30
Completion
2014-06-30

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 NCT01654224 on ClinicalTrials.gov