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The purpose of this study is to evaluate immunological efficacy and safety of GC3110A among healthy adults over 65 years of age.
Adults over 65 years of age will be once administered GC3110A(Quadrivalent influenza vaccine).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC3110A vaccine group | Experimental | Participants administered a single dose of GC3110A(Quadrivalent Influenza Vaccine). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC3110A vaccine | Biological | 0.5mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination | Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination | Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination) |
| Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination | Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination | Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the GC3110A Before and Following Vaccination | Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the GC3110A Before and Following Vaccination | Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic Univ. of Korea Daejeon St.Mary's Hospital | Daejeon | South Korea | ||||
| Soon Chun Hyang University Bucheon Hospital |
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| Gyeonggi-do |
| South Korea |
| The Catholic Univ.of Korea Bucheon St.Mary's Hospital | Gyeonggi-do | South Korea |
| The Catholic Univ.of Korea Uijeongbu St.Mary's Hospital | Gyeonggi-do | South Korea |
| EWHA woman's university mokdong hospital | Seoul | South Korea |
| KyungHee University Medical Center | Seoul | South Korea |
| Soon Chun Hyang University Seoul Hospital | Seoul | South Korea |
| The Catholic Univ. of Korea Incheon St.Mary's Hospital | Seoul | South Korea |
| The Catholic Univ.of Korea Seoul St.Mary's Hospital | Seoul | South Korea |
| The Catholic Univ.of Korea Yeouido St.Mary's Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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