Influenza Clinical Trial
Official title:
A Phase 3, Open Label, Uncontrolled, Multicenter Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Influenza Vaccine (Fluvirin®), Formulation 2012/2013, When Administered to Adult and Elderly Subjects
This protocol was designed to evaluate the safety, clinical tolerability and immunogenicity
of the Trivalent Influenza Virus Vaccine (TIVf, purified surface antigen, inactivated, egg
derived), Northern Hemisphere formulation 2012/2013. The principal aim was to provide safety
and immunogenicity data, in compliance to current EU Guidelines, with the intent of
obtaining marketing approval of the vaccine formulation intended for use prior to the next
influenza season in the Northern Hemisphere.
The antibody response to each influenza vaccine antigen, was measured by hemagglutination
inhibition (HI) and single radial hemolysis (SRH) at approximately 21 days postimmunization
in adult and elderly subjects. The safety and immunogenicity of a single intramuscular (IM)
injection of the vaccine was evaluated in compliance with the requirements of the current EU
recommendations for clinical trials related to yearly licensing of influenza vaccines
(CPMP/BWP/214/96).
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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