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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00232947
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : January 22, 2007
Information provided by:
ID Biomedical Corporation, Quebec

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Influenza virus vaccine (Fluviral) Biological: Influenza virus vaccine (Fluzone) Phase 3

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  (Clinical Trial)
Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Educational/Counseling/Training
Official Title: 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
Study Start Date : October 2005
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Primary Outcome Measures :
  1. Rate of signficant rises in serum antibody titers against viruses in the vaccines.
  2. Geometric mean serum antibody titers on day 21.

Secondary Outcome Measures :
  1. Rates of specific, solicited vaccine reactogenicicty complaints.
  2. Rates of adverse events.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00232947

United States, Florida
University Clinical Research, Inc.
Pembroke Pines, Florida, United States, 33024
United States, Georgia
Radiant Research
Atlanta, Georgia, United States, 30342
United States, Illinois
Radiant Research
Chicago, Illinois, United States, 60610
United States, Kansas
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66211
United States, Missouri
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
United States, New York
Regional Clinical Research
Endwell, New York, United States, 13760
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Ohio
Radiant Research
Cincinnati, Ohio, United States, 45236
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, Virginia
PI-Coor Clinical Research
Fairfax, Virginia, United States, 22030
Sponsors and Collaborators
ID Biomedical Corporation, Quebec
Study Director: Nancy Bouveret, MD ID Biomedical of Quebec Identifier: NCT00232947     History of Changes
Other Study ID Numbers: IDB707-108
First Posted: October 5, 2005    Key Record Dates
Last Update Posted: January 22, 2007
Last Verified: October 2005

Keywords provided by ID Biomedical Corporation, Quebec:

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs