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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Influenza

Intervention / Treatment
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* Biological: Influenza virus vaccine (Fluviral)
* Biological: Influenza virus vaccine (Fluzone)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Influenza virus vaccine (Fluviral)|nan|
|Biological: Influenza virus vaccine (Fluzone)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of specific, solicited vaccine reactogenicicty complaints. |  |  | 
| Rates of adverse events. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine, elderly, immunogenicity, safety