Status:
COMPLETED
Study Comparing Immune Response to, and Safety of, Fluviral and Fluzone Influenza Vaccines in Persons 50 y.o. and Over
Lead Sponsor:
ID Biomedical Corporation, Quebec
Conditions:
Influenza
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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 currentl...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT00232947
Start Date
October 1 2005
End Date
February 1 2006
Last Update
January 22 2007
Active Locations (10)
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1
University Clinical Research, Inc.
Pembroke Pines, Florida, United States, 33024
2
Radiant Research
Atlanta, Georgia, United States, 30342
3
Radiant Research
Chicago, Illinois, United States, 60610
4
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66211