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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
ECT
Masking
DOUBLE
Enrollment
900
University Clinical Research, Inc.
Pembroke Pines, Florida, United States
Radiant Research
Atlanta, Georgia, United States
Radiant Research
Chicago, Illinois, United States
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.
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