Study Comparing Immune Response to, and Safety of, Fluviral and Fluzone Influenza Vaccines in Persons 50 y.o. and Over
Information source: ID Biomedical Corporation, Quebec
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Influenza
Intervention: Influenza virus vaccine (Fluviral) (Biological); Influenza virus vaccine (Fluzone) (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: ID Biomedical Corporation, Quebec Official(s) and/or principal investigator(s):
Nancy Bouveret, MD, Study Director, Affiliation: ID Biomedical of Quebec
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.
Clinical Details
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 design: Educational/Counseling/Training, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Rate of signficant rises in serum antibody titers against viruses in the vaccines.Geometric mean serum antibody titers on day 21.
Secondary outcome: Rates of specific, solicited vaccine reactogenicicty complaints.Rates of adverse events.
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
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
University Clinical Research, Inc., Pembroke Pines, Florida 33024, United States
Radiant Research, Atlanta, Georgia 30342, United States
Radiant Research, Chicago, Illinois 60610, United States
Vince and Associates Clinical Research, Overland Park, Kansas 66211, United States
The Center for Pharmaceutical Research, Kansas City, Missouri 64114, United States
Regional Clinical Research, Endwell, New York 13760, United States
University of Rochester Medical Center, Rochester, New York 14642, United States
Radiant Research, Cincinnati, Ohio 45236, United States
Omega Medical Research, Warwick, Rhode Island 02886, United States
PI-Coor Clinical Research, Fairfax, Virginia 22030, United States
Additional Information
Starting date: October 2005
Ending date: February 2006
Last updated: January 19, 2007
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