Human Influenza Clinical Trial
Official title:
A Phase II, Open-Label, Single-Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of a Surface Antigen, Inactivated, Egg-Derived, Trivalent Influenza (Agrippal®) Virus Vaccine, Southern Hemisphere Formulation 2015, in Healthy Adults.
The present study is designed to evaluate the safety and immunogenicity of trivalent,
surface antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61
years.
For the immunogenicity endpoint the antibody response to each influenza vaccine antigen will
be evaluated by means of Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI)
at approximately 21 days post vaccination.
The vaccine composition will be based on the WHO recommended influenza strains for the 2015
Southern Hemisphere vaccine, and the data from this study are intended to support the use of
this vaccine in future influenza seasons if the recommended vaccine composition remains the
same.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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