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Study Comparing Immune Response to, and Safety of, Fluviral and Fluzone Influenza Vaccines in Persons 50 y.o. and Over

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Influenza virus vaccine (Fluviral)
Influenza virus vaccine (Fluzone)
Sponsored by
ID Biomedical Corporation, Quebec
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Influenza focused on measuring vaccine, elderly, immunogenicity, safety

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Stable health status Access to a consistent means of telephone contact. Comprehension of study requirements, availability for study duration Availability and ability to attend scheduled visits Females post menopausal, sterile or using accepted contraceptive measures Competence to provide informed consent Exclusion Criteria: Presence of significant acute or chronic medical or neuropsych. illness New medical or surgical treatment w/i 1 month Change in medication dose due to uncontrolled symptoms w/i 1 month Hospitalization w/i 1 month Any unusual risk (for age group) of serious adverse events w/i 1 month Any neuropsychiatric condition altering competence for consent Any neuropsychiatric condition preventing accurate safety reports Febrile illness on day of treatment Employment in professions at high risk of influenza transmission Residence in a long-term-care facility or with an immunocompromised person Systolic BP over 150, diastolic over 90, resting pulse under 50 or over 100 Cancer w/i 3 years Immunosuppressive of immunodeficient conditions Treatment with systemic glucocorticoids > replacement Treatment with cytotoxic or immunosuppressant drugs Treatment with immune globulins Clotting disorders that increase the risks of intramuscular injections History of demyelinating disease or GBS Pregnancy or nursing Absence of contraceptive practices in women with childbearing potential Planned administration of non-influenza vaccines within 30 days Receipt of any investigational drug within 30 days Receipt of immune globulin treatment within 3 months Known or suspected allergy to egg proteins, gelatin, or thimerosal History of severe adverse reactions toflu vaccines Prior receipt of 2005-6 influenza vaccine

Sites / Locations

  • University Clinical Research, Inc.
  • Radiant Research
  • Radiant Research
  • Vince and Associates Clinical Research
  • The Center for Pharmaceutical Research
  • Regional Clinical Research
  • University of Rochester Medical Center
  • Radiant Research
  • Omega Medical Research
  • PI-Coor Clinical Research

Outcomes

Primary Outcome Measures

Rate of signficant rises in serum antibody titers against viruses in the vaccines.
Geometric mean serum antibody titers on day 21.

Secondary Outcome Measures

Rates of specific, solicited vaccine reactogenicicty complaints.
Rates of adverse events.

Full Information

First Posted
October 3, 2005
Last Updated
January 19, 2007
Sponsor
ID Biomedical Corporation, Quebec
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1. Study Identification

Unique Protocol Identification Number
NCT00232947
Brief Title
Study Comparing Immune Response to, and Safety of, Fluviral and Fluzone Influenza Vaccines in Persons 50 y.o. and Over
Official Title
A Non-Inferiority Comparison of Fluviral™ Influenza Vaccine to a U.S. Licensed Inactivated Split-Virion Vaccine (Fluzone®) in Adults ≥ 50 Years Old Living in the Community
Study Type
Interventional

2. Study Status

Record Verification Date
October 2005
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
ID Biomedical Corporation, Quebec

4. Oversight

5. Study Description

Brief Summary
The goal of this study is to determine whether the immune responses induced by Fluviral, the investigational vaccine, are comparable to those induced by Fluzone, which is an influenza vaccine currently licensed in the U.S. The study focuses on persons 50 years old and over. In addition, the study will compare the rate of reactions to the two vaccines, and the general health of persons who receive them over the 42 days after immunization.
Detailed Description
Yearly influenza epidemics are responsible for excess hospitalizations and deaths in the elderly population, and also cause lost work and productivity among the healthy, working elderly. Fluviral, a product now licensed in Canada, is being tested to determine whether it is as active in causing immune responses, and as safe as a currently licensed U.S. vaccine in persons 50 y.o. and over.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
vaccine, elderly, immunogenicity, safety

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
900 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Influenza virus vaccine (Fluviral)
Intervention Type
Biological
Intervention Name(s)
Influenza virus vaccine (Fluzone)
Primary Outcome Measure Information:
Title
Rate of signficant rises in serum antibody titers against viruses in the vaccines.
Title
Geometric mean serum antibody titers on day 21.
Secondary Outcome Measure Information:
Title
Rates of specific, solicited vaccine reactogenicicty complaints.
Title
Rates of adverse events.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Stable health status Access to a consistent means of telephone contact. Comprehension of study requirements, availability for study duration Availability and ability to attend scheduled visits Females post menopausal, sterile or using accepted contraceptive measures Competence to provide informed consent Exclusion Criteria: Presence of significant acute or chronic medical or neuropsych. illness New medical or surgical treatment w/i 1 month Change in medication dose due to uncontrolled symptoms w/i 1 month Hospitalization w/i 1 month Any unusual risk (for age group) of serious adverse events w/i 1 month Any neuropsychiatric condition altering competence for consent Any neuropsychiatric condition preventing accurate safety reports Febrile illness on day of treatment Employment in professions at high risk of influenza transmission Residence in a long-term-care facility or with an immunocompromised person Systolic BP over 150, diastolic over 90, resting pulse under 50 or over 100 Cancer w/i 3 years Immunosuppressive of immunodeficient conditions Treatment with systemic glucocorticoids > replacement Treatment with cytotoxic or immunosuppressant drugs Treatment with immune globulins Clotting disorders that increase the risks of intramuscular injections History of demyelinating disease or GBS Pregnancy or nursing Absence of contraceptive practices in women with childbearing potential Planned administration of non-influenza vaccines within 30 days Receipt of any investigational drug within 30 days Receipt of immune globulin treatment within 3 months Known or suspected allergy to egg proteins, gelatin, or thimerosal History of severe adverse reactions toflu vaccines Prior receipt of 2005-6 influenza vaccine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Bouveret, MD
Organizational Affiliation
ID Biomedical of Quebec
Official's Role
Study Director
Facility Information:
Facility Name
University Clinical Research, Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Radiant Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Radiant Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Vince and Associates Clinical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
The Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Regional Clinical Research
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Radiant Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
PI-Coor Clinical Research
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study Comparing Immune Response to, and Safety of, Fluviral and Fluzone Influenza Vaccines in Persons 50 y.o. and Over

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