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

Sponsor:	ID Biomedical Corporation, Quebec
Information provided by:	ID Biomedical Corporation, Quebec
ClinicalTrials.gov Identifier:	NCT00232947

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 III

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

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

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

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

Keywords provided by ID Biomedical Corporation, Quebec:

vaccine
elderly
immunogenicity
safety

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010