Study Comparing Immune Response to, and Safety of, Fluviral and Fluzone Influenza Vaccines in Persons 50 y.o. and Over
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
1 other identifier
interventional
900
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2005
Shorter than P25 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 3, 2005
CompletedFirst Posted
Study publicly available on registry
October 5, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedJanuary 22, 2007
October 1, 2005
October 3, 2005
January 19, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of signficant rises in serum antibody titers against viruses in the vaccines.
Geometric mean serum antibody titers on day 21.
Secondary Outcomes (2)
Rates of specific, solicited vaccine reactogenicicty complaints.
Rates of adverse events.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024, United States
Radiant Research
Atlanta, Georgia, 30342, United States
Radiant Research
Chicago, Illinois, 60610, United States
Vince and Associates Clinical Research
Overland Park, Kansas, 66211, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
Regional Clinical Research
Endwell, New York, 13760, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Radiant Research
Cincinnati, Ohio, 45236, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
PI-Coor Clinical Research
Fairfax, Virginia, 22030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nancy Bouveret, MD
ID Biomedical of Quebec
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- ECT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 3, 2005
First Posted
October 5, 2005
Study Start
October 1, 2005
Study Completion
February 1, 2006
Last Updated
January 22, 2007
Record last verified: 2005-10