Study Comparing Immune Response to, and Safety of, Fluviral and Fluzone Influenza Vaccines in Persons 50 y.o. and Over
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.
Biological: Influenza virus vaccine (Fluviral)
Biological: Influenza virus vaccine (Fluzone)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Educational/Counseling/Training
|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|
- Rate of signficant rises in serum antibody titers against viruses in the vaccines.
- Geometric mean serum antibody titers on day 21.
- Rates of specific, solicited vaccine reactogenicicty complaints.
- Rates of adverse events.
|Study Start Date:||October 2005|
|Estimated Study Completion Date:||February 2006|
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.
|United States, Florida|
|University Clinical Research, Inc.|
|Pembroke Pines, Florida, United States, 33024|
|United States, Georgia|
|Atlanta, Georgia, United States, 30342|
|United States, Illinois|
|Chicago, Illinois, United States, 60610|
|United States, Kansas|
|Vince and Associates Clinical Research|
|Overland Park, Kansas, United States, 66211|
|United States, Missouri|
|The Center for Pharmaceutical Research|
|Kansas City, Missouri, United States, 64114|
|United States, New York|
|Regional Clinical Research|
|Endwell, New York, United States, 13760|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|United States, Ohio|
|Cincinnati, Ohio, United States, 45236|
|United States, Rhode Island|
|Omega Medical Research|
|Warwick, Rhode Island, United States, 02886|
|United States, Virginia|
|PI-Coor Clinical Research|
|Fairfax, Virginia, United States, 22030|
|Study Director:||Nancy Bouveret, MD||ID Biomedical of Quebec|