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The primary objective is to demonstrate the immunological non-inferiority between GC3102C and GC FLU inj. influenza vaccines by assessing geometric mean titers(GMTs) in healthy adults
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC FLU inj. | Active Comparator | Influneza vaccine, single-dose vial |
|
| GC3102C | Experimental | Influneza vaccine, multi-dose vial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC3102C | Biological | a single dose (0.5 mL) intramuscularly on the deltoid muscle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| GMT, using the Hemagglutination inhibition(HI) antibody titer | Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of subjects achieving seroconversion | Day 0 , Day 21 | |
| Rate of subjects achieving seroprotection | Day 21 | |
| Number of Participants Reporting a Solicited Adverse Events After Vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| GC FLU inj. |
| Biological |
a single dose (0.5 mL) intramuscularly on the deltoid muscle |
|
| Day 6 |
| Number of Participants Reporting a Unsolicited Adverse Events After Vaccination | Day 21 |