Influenza Clinical Trial
Vaccination against influenza is a high priority for the elderly population who present the
highest morbidity and mortality rate. However, due to their weak antibody response an
improvement of the immune response to influenza vaccination remains an unmet medical need.
The purpose of an investigational influenza vaccine candidate administered by an alternate
route is to improve immune responses to the vaccine in the elderly population, which could
provide additional reductions in influenza-associated morbidity and mortality in this
population.
Primary Objective:
To demonstrate that the investigational vaccine induces a better immunogenicity than the
reference vaccine in terms of seroprotection rate after the first vaccination.
Secondary Objectives:
Immunogenicity:
To describe the antibody persistence induced by both vaccines at 3, 6, and 12 months after
the first vaccination in a subset of subjects.
To describe the immunogenicity of the investigational vaccine after each vaccination using
parameters defined in the European Medicines Agency (EMEA) Note for Guidance
(CPMP/BWP/214/96) specific to elderly subjects.
Safety:
To demonstrate the tolerance of the investigational vaccine after the first vaccination, in
terms of pre-defined solicited systemic reactions.
To describe the safety profile after each vaccination. To describe the effect of repetitive
injections on the safety profile.
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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