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This trial is to investigate the clinically recommended dosage for ASP7373 based on the comparison of the immunogenicity and safety among the three doses of ASP7373 in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Saline |
|
| Dose -1 | Experimental | ASP7373 |
|
| Dose -2 | Experimental | ASP7373 |
|
| Dose -3 | Experimental | ASP7373 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP7373 | Biological | Intermuscular administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs | up to 43 days | |
| Immunogenicity (HI antibody titer)- first vaccine | on Day 21 | |
| Immunogenicity (HI antibody titer)- second vaccine | second vaccination on Day 22 | on Day 43 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyushu | Japan |
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| Placebo | Biological | Intramuscular administration |
|