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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
ID Biomedical Corporation, Quebec

September 20, 2005
September 22, 2005
December 11, 2006
September 2005
Not Provided
Incidence of culture confirmed influenza-like illness due to virus strains matching the vaccine during the interval from November to April following treatment.
Incidence of culture confirmed influenza-like illness during the interval from November to April following treatment.
Complete list of historical versions of study NCT00216242 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 apporximately 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.
Not Provided
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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
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Educational/Counseling/Training
Influenza
  • Biological: Influenza virus vaccine (Fluviral)
  • Biological: Saline placebo
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
7400
6374
May 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years to 49 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00216242
IDB707-106
Not Provided
Not Provided
Not Provided
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ID Biomedical Corporation, Quebec
Not Provided
Study Director: Nancy Bouveret, MD ID Biomedical of Quebec
ID Biomedical Corporation, Quebec
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP