Human Influenza Clinical Trial
Official title:
A Phase II, Open-Label, Single-Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of a Trivalent, Surface Antigen Inactivated Subunit Influenza Virus Vaccine (Agrippal®) in Healthy Adults
The present study is designed to confirm 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
2013/2014 Northern Hemisphere vaccine, and the results of this study are intended to support
the use of this vaccine in future influenza seasons if the recommended vaccine composition
remains the same, in compliance with the requirements of the current European Union (EU)
recommendations for clinical trials related to yearly licensing of influenza vaccines.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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