Study of the Protective Effect of an Injectable Influenza Vaccine Against Influenza Illness in Adults Under 50 y.o.
A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy of Fluviral™ Influenza Vaccine in Healthy Adults 18 to 49 Years of Age
1 other identifier
interventional
7,400
1 country
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2005
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 20, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedDecember 11, 2006
December 1, 2006
September 20, 2005
December 8, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of culture confirmed influenza-like illness due to virus strains matching the vaccine during the interval from November to April following treatment.
Secondary Outcomes (6)
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;
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Good health by history and physical exam
- Reliable access to a telephone
- Study comprehension and informed consent
You may not qualify if:
- 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:
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Benchmark Research
Sacramento, California, 95816, United States
Benchmark Research
San Francisco, California, 94102, United States
Radiant Research
Denver, Colorado, 80212, United States
Longmont Med. Research Center
Longmont, Colorado, 80501, United States
Miami Research Associates
Miami, Florida, 33173, United States
University Clinical Research Associates
Pembroke Pines, Florida, 33024, United States
Emory University
Atlanta, Georgia, 30322, United States
Radiant Research
Atlanta, Georgia, 30342, United States
Dwight D. Eisenhower Army Medical Center
Fort Eisenhower, Georgia, 30905-5650, United States
Advanced Clinical Research
Boise, Idaho, 83704, United States
Radiant Research
Boise, Idaho, 83704, United States
Radiant Research
Chicago, Illinois, 60610, United States
Preventive Intervention Center
Iowa City, Iowa, 52242-1009, United States
Johnson County ClinTrials
Lenexa, Kansas, 66219, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004, United States
Rockville Internal Medicine Group
Rockville, Maryland, 20854, United States
Meridian Clinical Research
Omaha, Nebraska, 68134, United States
Anderson and Collins Clinical Research
Edison, New Jersey, 08817, United States
Regional Clinical Research
Endwell, New York, 13760, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
National Carolina Children and Adult Clinical Research Foundation
Sylva, North Carolina, 28779, United States
Carolina medical Trials
Winston-Salem, North Carolina, 27103, United States
Radiant Research
Cincinnati, Ohio, 45236, United States
Brandywine Clinical Research
Downingtown, Pennsylvania, 19355, United States
Omega Clinical Trials
Warwick, Rhode Island, 02886, United States
Radiant Research
Anderson, South Carolina, 29611, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
Clinical Research Associates
Nashville, Tennessee, 37203, United States
Benchmark Research
Austin, Texas, 78705, United States
Benchmark Research
Austin, Texas, 78728, United States
Covance
Austin, Texas, 78752, United States
Allergy and Asthma Research Associates
Dallas, Texas, 75231, United States
Research Across America
Dallas, Texas, 75234, United States
Benchmark Research
Fort Worth, Texas, 76135, United States
Killeen Scott and White Regional Clinic
Killeen, Texas, 76543, United States
Research Across America
Plano, Texas, 75093, United States
Benchmark Research
San Angelo, Texas, 16904, United States
J. Lewis Research, Inc.
Salt Lake City, Utah, 84109, United States
J. Lewis Research, Inc.
Salt Lake City, Utah, 84121, United States
J. Lewis Research
West Jordan, Utah, 84084, United States
PI-Coor Clinical Research, LLC
Burke, Virginia, 22015, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507, United States
Center for Health Studies
Seattle, Washington, 98101, United States
Related Publications (1)
Jackson LA, Gaglani MJ, Keyserling HL, Balser J, Bouveret N, Fries L, Treanor JJ. Safety, efficacy, and immunogenicity of an inactivated influenza vaccine in healthy adults: a randomized, placebo-controlled trial over two influenza seasons. BMC Infect Dis. 2010 Mar 17;10:71. doi: 10.1186/1471-2334-10-71.
PMID: 20236548DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nancy Bouveret, MD
ID Biomedical of Quebec
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- ECT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 20, 2005
First Posted
September 22, 2005
Study Start
September 1, 2005
Study Completion
May 1, 2007
Last Updated
December 11, 2006
Record last verified: 2006-12