At a glance
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A Phase 2, Open Label, Uncontrolled, Multicenter Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine (Fluad®), Formulation 2012/2013, When Administered to Elderly Subjects
In Brief
A Phase 2 clinical trial evaluating Adjuvanted Trivalent Influenza Virus Vaccine (aTIV) for Human Influenza. Completed, enrolled 63 participants across 1 site.
Detailed Summary
To evaluate the safety of a single intramuscular (IM) injection of trivalent adjuvanted influenza study vaccine, formulation 2012/2013, in elderly subjects and the antibody response to each influenza vaccine antigen, as measured by single radial hemolysis (SRH) and hemagglutination inhibition (HI) at approximately 21 days postimmunization in elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.
Study Details
Timeline
Interventions
A single 0.5 mL dose of study vaccine supplied in prefilled syringes was administered intramuscularly in the deltoid muscle, preferably of the non dominant arm.