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

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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