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| Name | Class |
|---|---|
| Korean Center for Disease Control and Prevention | OTHER_GOV |
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The purpose of this study is to 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 | Experimental | MG1109 0.5 mL Intramuscularly injection, twice at an interval of 21 days |
|
| Placebo | Placebo Comparator | Placebo(for MG1109) 0.5 mL Intramuscularly injection, twice at an interval of 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MG1109 | Biological |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40 | 1st vaccination ~ 21 days after 2nd vaccination | |
| Percentage of subjects achieving post-vaccination seroconversion for Hemagglutination Inhibition(HI) antibody | 1st vaccination ~ 21 days after 2nd vaccination | |
| GMR(Geometric Mean Ratio) of Hemagglutination Inhibition(HI) antibody titer at post-vaccination compared to pre-vaccination | 1st vaccination ~ 21 days after 2nd vaccination | |
| The percentage of subjects reporting solicited adverse events from the date of vaccination until 7 days after each vaccination | Each vaccination ~ 7 days after each vaccination | |
| The percentage of subjects reporting unsolicited adverse events from the date of 1st vaccination until 24weeks after 2nd vaccination | 1st vaccination ~ 24 weeks after 2nd vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| GMT(Geometric Mean Titer) of Hemagglutination Inhibition(HI) antibody titer pre-vaccination and post-vaccination | 1st vaccination ~ 21 days after 2nd vaccination | |
| GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio) of neutralizing antibody titer pre-vaccination and post-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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|
| 1st vaccination ~ 21 days after 2nd vaccination |
| Vital signs(body temperature, pulse) | 1st vaccination ~ 21 days after 2nd vaccination |
| The results of physical examinations | 1st vaccination ~ 21 days after 2nd vaccination |
| Lab results(Hematology, Blood chemistry, Urinalysis) | 1st vaccination ~ 21 days after 2nd vaccination |
| 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 |