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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AdimFlu-S 2011-2012 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-elderly aged between 18 and 60 | Biological | one dose of 0.5mL AdimFlu-S |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 weeks post vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gin-Hsiang Wu, MD | National Cheng-Kung University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Tainan | Taiwan |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| elderly aged over 60 |
| Biological |
one dose of 0.5mL AdimFlu-S |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |