Study of the Protective Effect of an Injectable Influenza Vaccine Against Influenza Illness in Adults Under 50 y.o.
- Conditions
- Influenza
- Registration Number
- NCT00216242
- Lead Sponsor
- ID Biomedical Corporation, Quebec
- 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 limit normal daily activities and that are shown by virus culture to be caused by influenza viruses. The study will also examine the safety of the vaccine and collect measurements of the immune system responses produced by the vaccine.
- 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 believed to be effective, but formal studies using modern culture methods to prove this are limited. This study will compare the rate of respiratory illnesses associated with positive influenza virus cultures in healthy younger adults (a group at low risk for serious influenza complications) who have received Fluviral (an injectable flu vaccine) with the rate of such illnesses in healthy younger adults who have received an injection of saline (salt water). The rate of local vaccine reactions and other symptoms will be compared between the vaccine and salt water groups, and the immune responses to the vaccine measured.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 7400
- Good health by history and physical exam
- Reliable access to a telephone
- Study comprehension and informed consent
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Systolic BP >/= 140; diastolic BP >/= 90
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Uncontrolled medical or psychiatric illness (change in last 3 months)
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Cancer, or treatment for cancer within 3 years
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Cardio-pulmonary disease requiring chronic treatment
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Insulin dependent diabetes mellitus
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Renal dysfunction (creatinine >/= 1.7 mg/dL)
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Hemoglobinopathies
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Clotting disorders that increase the risk of IM injections
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Immunosuppressive illnesses or drugs
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History of demyelinating disease (esp. Guillian-Barre syndrome)
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Employment in professions at high risk for influenza transmission
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Household contact with high-risk individuals
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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
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History of:
- Severe reactions to other influenza vaccines
- Allergy to egg proteins
- Sensitivity to mercurials
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Pregnancy/ high risk of pregnancy
- Positive urine pregnancy test before treatment
- Women of child-bearing potential without credible contraceptive plan
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of culture confirmed influenza-like illness due to virus strains matching the vaccine during the interval from November to April following treatment.
- Secondary Outcome Measures
Name Time Method Incidence of culture and/or serologically-confirmed influenza-like illness during the interval from November to April following treatment; Rate of solicited local and systemic common reactions in days 0 to 3 post-treatment; Rate of other adverse events through approximately 135 days post-treatment; Rate of four-fold rises in influenza specific antibody titers 21 days after treatment; Rate of influenza-specific antibody titers equal to, or greater than, 40 at 21 days after treatment; Geometric mean influenza-specific antibody titers at 21 days after treatment.
Trial Locations
- Locations (31)
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Allergy and Asthma Research Associates
🇺🇸Dallas, Texas, United States
Advanced Clinical Research
🇺🇸Boise, Idaho, United States
Meridian Clinical Research
🇺🇸Omaha, Nebraska, United States
Longmont Med. Research Center
🇺🇸Longmont, Colorado, United States
Kentucky Pediatric/Adult Research
🇺🇸Bardstown, Kentucky, United States
Anderson and Collins Clinical Research
🇺🇸Edison, New Jersey, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
University Clinical Research Associates
🇺🇸Pembroke Pines, Florida, United States
Benchmark Research
🇺🇸San Angelo, Texas, United States
Brandywine Clinical Research
🇺🇸Downingtown, Pennsylvania, United States
Covance
🇺🇸Austin, Texas, United States
Dwight D. Eisenhower Army Medical Center
🇺🇸Ft. Gordon, Georgia, United States
J. Lewis Research
🇺🇸West Jordan, Utah, United States
Rockville Internal Medicine Group
🇺🇸Rockville, Maryland, United States
Omega Clinical Trials
🇺🇸Warwick, Rhode Island, United States
PI-Coor Clinical Research, LLC
🇺🇸Burke, Virginia, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Center for Health Studies
🇺🇸Seattle, Washington, United States
Johnson County ClinTrials
🇺🇸Lenexa, Kansas, United States
National Carolina Children and Adult Clinical Research Foundation
🇺🇸Sylva, North Carolina, United States
Preventive Intervention Center
🇺🇸Iowa City, Iowa, United States
J. Lewis Research, Inc.
🇺🇸Salt Lake City, Utah, United States
Regional Clinical Research
🇺🇸Endwell, New York, United States
Carolina medical Trials
🇺🇸Winston-Salem, North Carolina, United States
Clinical Research Associates of Tidewater
🇺🇸Norfolk, Virginia, United States
Research Across America
🇺🇸Plano, Texas, United States
Clinical Research Associates
🇺🇸Nashville, Tennessee, United States
Killeen Scott and White Regional Clinic
🇺🇸Killeen, Texas, United States
Radiant Research
🇺🇸Anderson, South Carolina, United States