The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HAI) at 21 days post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
128
one dose of 0.5mL AdimFlu-S
one dose of 0.5mL AdimFlu-S
National Cheng Kung University Hospital
Tainan, Taiwan
The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 40.
Serum samples will be tested for anti-hemagglutinin (HA) antibodies by hemagglutination inhibition (HAI).
Time frame: 3 weeks post vaccination
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