Study of the Protective Effect of an Injectable Influenza Vaccine Against Influenza Illness in Adults Under 50 y.o.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00216242
Recruitment Status : Unknown
Verified December 2006 by ID Biomedical Corporation, Quebec.
Recruitment status was:  Active, not recruiting
First Posted : September 22, 2005
Last Update Posted : December 11, 2006
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Influenza virus vaccine (Fluviral) Biological: Saline placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 7400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Educational/Counseling/Training
Official Title: A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy of Fluviral™ Influenza Vaccine in Healthy Adults 18 to 49 Years of Age
Study Start Date : September 2005
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Primary Outcome Measures :
  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 Outcome Measures :
  1. Incidence of culture and/or serologically-confirmed influenza-like illness during the interval from November to April following treatment;
  2. Rate of solicited local and systemic common reactions in days 0 to 3 post-treatment;
  3. Rate of other adverse events through approximately 135 days post-treatment;
  4. Rate of four-fold rises in influenza specific antibody titers 21 days after treatment;
  5. Rate of influenza-specific antibody titers equal to, or greater than, 40 at 21 days after treatment;
  6. Geometric mean influenza-specific antibody titers at 21 days after treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Good health by history and physical exam
  • Reliable access to a telephone
  • Study comprehension and informed consent

Exclusion Criteria:

  • 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:

    1. Severe reactions to other influenza vaccines
    2. Allergy to egg proteins
    3. Sensitivity to mercurials
  • Pregnancy/ high risk of pregnancy

    1. Positive urine pregnancy test before treatment
    2. Women of child-bearing potential without credible contraceptive plan

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00216242

  Hide Study Locations
United States, California
Benchmark Research
Sacramento, California, United States, 95816
Benchmark Research
San Fransisco, California, United States, 94102
United States, Colorado
Radiant Research
Denver, Colorado, United States, 80212
Longmont Med. Research Center
Longmont, Colorado, United States, 80501
United States, Florida
Miami Research Associates
Miami, Florida, United States, 33173
University Clinical Research Associates
Pembroke Pines, Florida, United States, 33024
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Radiant Research
Atlanta, Georgia, United States, 30342
Dwight D. Eisenhower Army Medical Center
Ft. Gordon, Georgia, United States, 30905-5650
United States, Idaho
Advanced Clinical Research
Boise, Idaho, United States, 83704
Radiant Research
Boise, Idaho, United States, 83704
United States, Illinois
Radiant Research
Chicago, Illinois, United States, 60610
United States, Iowa
Preventive Intervention Center
Iowa City, Iowa, United States, 52242-1009
United States, Kansas
Johnson County ClinTrials
Lenexa, Kansas, United States, 66219
United States, Kentucky
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States, 40004
United States, Maryland
Rockville Internal Medicine Group
Rockville, Maryland, United States, 20854
United States, Nebraska
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
United States, New Jersey
Anderson and Collins Clinical Research
Edison, New Jersey, United States, 08817
United States, New York
Regional Clinical Research
Endwell, New York, United States, 13760
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
National Carolina Children and Adult Clinical Research Foundation
Sylva, North Carolina, United States, 28779
Carolina medical Trials
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Radiant Research
Cincinnati, Ohio, United States, 45236
United States, Pennsylvania
Brandywine Clinical Research
Downingtown, Pennsylvania, United States, 19355
United States, Rhode Island
Omega Clinical Trials
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Radiant Research
Anderson, South Carolina, United States, 29611
Spartanburg Medical Research
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Clinical Research Associates
Nashville, Tennessee, United States, 37203
United States, Texas
Benchmark Research
Austin, Texas, United States, 78705
Benchmark Research
Austin, Texas, United States, 78728
Austin, Texas, United States, 78752
Allergy and Asthma Research Associates
Dallas, Texas, United States, 75231
Research Across America
Dallas, Texas, United States, 75234
Benchmark Research
Fort Worth, Texas, United States, 76135
Killeen Scott and White Regional Clinic
Killeen, Texas, United States, 76543
Research Across America
Plano, Texas, United States, 75093
Benchmark Research
San Angelo, Texas, United States, 16904
United States, Utah
J. Lewis Research, Inc.
Salt Lake City, Utah, United States, 84109
J. Lewis Research, Inc.
Salt Lake City, Utah, United States, 84121
J. Lewis Research
West Jordan, Utah, United States, 84084
United States, Virginia
PI-Coor Clinical Research, LLC
Burke, Virginia, United States, 22015
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States, 23507
United States, Washington
Center for Health Studies
Seattle, Washington, United States, 98101
Sponsors and Collaborators
ID Biomedical Corporation, Quebec
Study Director: Nancy Bouveret, MD ID Biomedical of Quebec

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00216242     History of Changes
Other Study ID Numbers: IDB707-106
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: December 11, 2006
Last Verified: December 2006

Keywords provided by ID Biomedical Corporation, Quebec:

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs