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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by ID Biomedical Corporation, Quebec.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
ID Biomedical Corporation, Quebec
ClinicalTrials.gov Identifier:
NCT00216242
First received: September 20, 2005
Last updated: December 8, 2006
Last verified: December 2006
  Purpose

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 Intervention Phase
Influenza
Biological: Influenza virus vaccine (Fluviral)
Biological: Saline placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by ID Biomedical Corporation, Quebec:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 7400
Study Start Date: September 2005
Estimated Study Completion Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216242

  Show 43 Study Locations
Sponsors and Collaborators
ID Biomedical Corporation, Quebec
Investigators
Study Director: Nancy Bouveret, MD ID Biomedical of Quebec
  More Information

No publications provided by ID Biomedical Corporation, Quebec

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00216242     History of Changes
Other Study ID Numbers: IDB707-106
Study First Received: September 20, 2005
Last Updated: December 8, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by ID Biomedical Corporation, Quebec:
influenza
vaccine
efficacy
safety
immunogenicity

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014