The purpose of this trial is to describe the immunogenicity, the safety, and tolerability of FluLaval™ TR and Fluarix®, the latter serving as active comparator. The results will be compared to a standard immune response criteria, for both young and elderly populations.
This randomized trial will assess the immune protection offered at Day 21 by FluLaval™ TR, Fluarix® being the comparator. In both groups, immune response will be assessed through a blood test before and 21 days following vaccination. The safety and tolerability of the study vaccine will be contrasted to the comparator vaccine over a period of 42 days following vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
660
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Lenexa, Kansas, United States
GSK Investigational Site
Binghamton, New York, United States
GSK Investigational Site
Austin, Texas, United States
21 days after vaccination: seroconversion rate, seroprotection rate,
geometric mean titer fold increase
Immediate AEs; solicited and spontaneous AEs within 42 days of vaccination;
SAEs over the whole study period
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GSK Investigational Site
Fort Worth, Texas, United States
GSK Investigational Site
Burke, Virginia, United States