The purpose of the study is to evaluate the safety, tolerance and immunogenicity of Fluviral™ in healthy adults aged 18-64 years.
This study was conducted by ID BioMedical which has been taken over by GlaxoSmithKline. At the time of conduct of this study, Fluviral was produced by ID BioMedical.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,000
Number of subjects with solicited local and systemic reactogenicity symptoms
Time frame: First three days after vaccination
Number of subjects reporting spontaneous adverse events
Time frame: Throughout the entire study period (Day 0-42)
Immune response in terms of number of seroconverted subjects
Time frame: Before (Day 0) and after (Day 21) vaccination
Immune response in terms of number of seroprotected subjects
Time frame: Before (Day 0) and after (Day 21) vaccination
Immunogenicity with respect to components of the study vaccine in terms of number of subjects with titres above the pre-defined cut-off
Titres calculated as geometric mean
Time frame: At Day 21 after vaccination
Immune response to components of the study vaccine in terms of mean Geometric increase
Time frame: At Day 21 after vaccination
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