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

This study has been completed.
Sponsor:
Information provided by:
ID Biomedical Corporation, Quebec
ClinicalTrials.gov Identifier:
NCT00232947
First received: October 3, 2005
Last updated: January 19, 2007
Last verified: October 2005
  Purpose

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 Intervention Phase
Influenza
Biological: Influenza virus vaccine (Fluviral)
Biological: Influenza virus vaccine (Fluzone)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by ID Biomedical Corporation, Quebec:

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

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

Estimated Enrollment: 900
Study Start Date: October 2005
Estimated Study Completion Date: February 2006
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232947

Locations
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
Investigators
Study Director: Nancy Bouveret, MD ID Biomedical of Quebec
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00232947     History of Changes
Other Study ID Numbers: IDB707-108
Study First Received: October 3, 2005
Last Updated: January 19, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by ID Biomedical Corporation, Quebec:
vaccine
elderly
immunogenicity
safety

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 28, 2014