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| Name | Class |
|---|---|
| Korean Center for Disease Control and Prevention | OTHER_GOV |
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This study was designed in two steps with Step 1, a single-center, double-blind, randomized clinical Pilot study and Step 2, a multi-center, single-blind, randomized clinical Pivotal study. The investigator evaluate the immunogenicity and safety of the investigational vaccine in the subjects during their participation in the study.
MG1109 is purified, inactivated influenza viral antigen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MG1109 - Step 1 | Experimental |
| |
| Normal Saline - Step 1 | Placebo Comparator |
| |
| MG1109 - Step 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Step 1 | Biological | Investigational Product : MG1109 Dose : Cohort 1 : 0.125 mL Cohort 2 :0.25 mL Cohort 3 :0.5 mL Cohort 4 :1.0 mL intramuscularly injection, twice at an interval of 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40 in each dose group | 42 days after vaccination | |
| Number of subjects with Solicited / Unsolicited adverse events | With in 24 weeks after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Woo Joo Kim, MD, Ph.D | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Ansan | South Korea | ||||
| Inha University Hospital |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D005585 | Influenza in Birds |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000601529 | SE 1-step Futurabond M |
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| Step 2 | Biological | Investigational Product : MG1109 Dose : Cohort 1 :0.5 mL Cohort 2 :1.0 mL intramuscularly injection, twice at an interval of 21 days |
|
| Inchon |
| South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Catholic University Of Korea ST. Vincent's Hospital | Suwon | South Korea |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D001715 | Bird Diseases |
| D000820 | Animal Diseases |