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The purpose of this study is to compare immunogenicity and safety of ASP7374 (cell-culture derived influenza vaccine) with those of approved egg-derived trivalent inactivated vaccine (TIV) in adults ≥20 and <65 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP7374 group | Experimental |
| |
| TIV group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP7374 | Biological | subcutaneous |
| |
| approved egg-derived TIV |
| Measure | Description | Time Frame |
|---|---|---|
| seroconversion rate of hemagglutination inhibition (HI) antibody titer | evaluated for A/H1N1, A/H3N2, and B | Day 29 |
| geometric mean titer (GMT) of HI antibody titer | evaluated for A/H1N1, A/H3N2, and B | Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| seroprotection rate of HI antibody titer | evaluated for A/H1N1, A/H3N2, and B | Day 29 |
| GMT ratio of HI antibody titer (Day 29/Day 1) | evaluated for A/H1N1, A/H3N2, and B |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanto | Japan | |||||
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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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| Biological |
subcutaneous |
|
|
| Day1 and Day 29 |
| seroconversion rate of neutralizing antibody titer | evaluated for A/H1N1, A/H3N2, and B | Day 29 |
| seroprotection of neutralizing antibody titer | evaluated for A/H1N1, A/H3N2, and B | Day 29 |
| GMT of neutralizing antibody titer | evaluated for A/H1N1, A/H3N2, and B | Day 29 |
| GMT ratio of neutralizing antibody titer (Day 29/Day 1) | evaluated for A/H1N1, A/H3N2, and B | Day 1 and Day 29 |
| Local and systemic reactions associated with the vaccination | Day 1 through Day 8 |
| Kyushu |
| Japan |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |