Influenza Clinical Trial
All marketed influenza vaccines are injected by the intramuscular (IM) route. This study
will test whether an influenza vaccine is effective when injected by a route other than into
the muscle. In order to prove this, the amount of antibodies in the blood will be measured
before and after vaccination. In addition, the safety of both influenza vaccines will be
tested by evaluating all serious reactions occurring after vaccination. The vaccine injected
in this study is similar to the sponsor's marketed intramuscular influenza vaccine
(Vaxigrip). In addition, the safety of both influenza vaccines administered by different
routes will be tested by evaluating all adverse events and especially all serious reactions.
Primary Objective: To demonstrate and compare the immune response of an influenza vaccine
after a single dose when administered by different routes.
Secondary Objectives: To describe the compliance of the immunogenicity of the vaccine with
the European Medicine Agency (EMEA) after the first injection.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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|---|---|---|---|
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||
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