Study Comparing Immune Response to, and Safety of, Fluviral and Fluzone Influenza Vaccines in Persons 50 y.o. and Over

January 19, 2007 updated by: ID Biomedical Corporation, Quebec

A Non-Inferiority Comparison of Fluviral™ Influenza Vaccine to a U.S. Licensed Inactivated Split-Virion Vaccine (Fluzone®) in Adults ≥ 50 Years Old Living in the Community

The goal of this study is to determine whether the immune responses induced by Fluviral, the investigational vaccine, are comparable to those induced by Fluzone, which is an influenza vaccine currently licensed in the U.S. The study focuses on persons 50 years old and over. In addition, the study will compare the rate of reactions to the two vaccines, and the general health of persons who receive them over the 42 days after immunization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Yearly influenza epidemics are responsible for excess hospitalizations and deaths in the elderly population, and also cause lost work and productivity among the healthy, working elderly. Fluviral, a product now licensed in Canada, is being tested to determine whether it is as active in causing immune responses, and as safe as a currently licensed U.S. vaccine in persons 50 y.o. and over.

Study Type

Interventional

Enrollment

900

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Pembroke Pines, Florida, United States, 33024
        • University Clinical Research, Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Radiant Research
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Radiant Research
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Vince and Associates Clinical Research
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • The Center for Pharmaceutical Research
    • New York
      • Endwell, New York, United States, 13760
        • Regional Clinical Research
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Radiant Research
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • Virginia
      • Fairfax, Virginia, United States, 22030
        • PI-Coor Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stable health status
  • Access to a consistent means of telephone contact.
  • Comprehension of study requirements, availability for study duration
  • Availability and ability to attend scheduled visits
  • Females post menopausal, sterile or using accepted contraceptive measures
  • Competence to provide informed consent

Exclusion Criteria:

  • Presence of significant acute or chronic medical or neuropsych. illness
  • New medical or surgical treatment w/i 1 month
  • Change in medication dose due to uncontrolled symptoms w/i 1 month
  • Hospitalization w/i 1 month
  • Any unusual risk (for age group) of serious adverse events w/i 1 month
  • Any neuropsychiatric condition altering competence for consent
  • Any neuropsychiatric condition preventing accurate safety reports
  • Febrile illness on day of treatment
  • Employment in professions at high risk of influenza transmission
  • Residence in a long-term-care facility or with an immunocompromised person
  • Systolic BP over 150, diastolic over 90, resting pulse under 50 or over 100
  • Cancer w/i 3 years
  • Immunosuppressive of immunodeficient conditions
  • Treatment with systemic glucocorticoids > replacement
  • Treatment with cytotoxic or immunosuppressant drugs
  • Treatment with immune globulins
  • Clotting disorders that increase the risks of intramuscular injections
  • History of demyelinating disease or GBS
  • Pregnancy or nursing
  • Absence of contraceptive practices in women with childbearing potential
  • Planned administration of non-influenza vaccines within 30 days
  • Receipt of any investigational drug within 30 days
  • Receipt of immune globulin treatment within 3 months
  • Known or suspected allergy to egg proteins, gelatin, or thimerosal
  • History of severe adverse reactions toflu vaccines
  • Prior receipt of 2005-6 influenza vaccine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Educational/Counseling/Training
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Rate of signficant rises in serum antibody titers against viruses in the vaccines.
Geometric mean serum antibody titers on day 21.

Secondary Outcome Measures

Outcome Measure
Rates of specific, solicited vaccine reactogenicicty complaints.
Rates of adverse events.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ID Biomedical Corporation, Quebec

Investigators

  • Study Director: Nancy Bouveret, MD, ID Biomedical of Quebec

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion

February 1, 2006

Study Registration Dates

First Submitted

October 3, 2005

First Submitted That Met QC Criteria

October 3, 2005

First Posted (Estimate)

October 5, 2005

Study Record Updates

Last Update Posted (Estimate)

January 22, 2007

Last Update Submitted That Met QC Criteria

January 19, 2007

Last Verified

October 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDB707-108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Influenza

Clinical Trials on Influenza virus vaccine (Fluviral)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe