Human Influenza Clinical Trial
Official title:
A Phase III, Open Label, Single Arm, Multi Center Study to Evaluate Safety and Immunogenicity of a Trivalent, Surface Antigen Inactivated Subunit Influenza Virus (Fluvirin®) 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 and
the antibody response to each influenza vaccine antigen, as measured by Single Radial
Hemolysis (SRH) or Hemagglutination Inhibition (HI) at approximately 21 days post
immunization.
The vaccine composition will be based on the World Health Organization (WHO) recommended
influenza strains for the 2013/2014 Northern Hemisphere vaccine.
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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