Status:
UNKNOWN
Study of the Protective Effect of an Injectable Influenza Vaccine Against Influenza Illness in Adults Under 50 y.o.
Lead Sponsor:
ID Biomedical Corporation, Quebec
Conditions:
Influenza
Eligibility:
All Genders
18-49 years
Phase:
PHASE3
Brief Summary
The goal of this study is to determine whether Fluviral, an inactivated, injectable trivalent influenza vaccine (flu shot) is effective in preventing respiratory illnesses that are severe enough to li...
Detailed Description
Yearly influenza (flu) epidemics cause a large burden of lost work and school time among younger persons and excess hospitalizations and deaths among the elderly. Injectable flu vaccines are generally...
Eligibility Criteria
Inclusion
- Good health by history and physical exam
- Reliable access to a telephone
- Study comprehension and informed consent
Exclusion
- Systolic BP \>/= 140; diastolic BP \>/= 90
- Uncontrolled medical or psychiatric illness (change in last 3 months)
- Cancer, or treatment for cancer within 3 years
- Cardio-pulmonary disease requiring chronic treatment
- Insulin dependent diabetes mellitus
- Renal dysfunction (creatinine \>/= 1.7 mg/dL)
- Hemoglobinopathies
- Clotting disorders that increase the risk of IM injections
- Immunosuppressive illnesses or drugs
- History of demyelinating disease (esp. Guillian-Barre syndrome)
- Employment in professions at high risk for influenza transmission
- Household contact with high-risk individuals
- Receipt of:
- a) Immunosuppressive drugs i) systemic glucocorticoids \>/= 10 mg prednisone per day ii) cytotoxic drugs b) Investigational drugs within 30 days before, or planned during, the study c) Blood products within 3 months before, or planned during, the study d) Influenza vaccine within 9 months before the study e) Other vaccines within 30 days before, or planned during, the study
- History of:
- Severe reactions to other influenza vaccines
- Allergy to egg proteins
- Sensitivity to mercurials
- Pregnancy/ high risk of pregnancy
- Positive urine pregnancy test before treatment
- Women of child-bearing potential without credible contraceptive plan
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
7400 Patients enrolled
Trial Details
Trial ID
NCT00216242
Start Date
September 1 2005
End Date
May 1 2007
Last Update
December 11 2006
Active Locations (43)
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1
Benchmark Research
Sacramento, California, United States, 95816
2
Benchmark Research
San Francisco, California, United States, 94102
3
Radiant Research
Denver, Colorado, United States, 80212
4
Longmont Med. Research Center
Longmont, Colorado, United States, 80501