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The purpose of this study is to evaluate immunological efficacy and safety of GC3110B versus GCFLU Quadrivalent Inj. among healthy adults in 18 to 60 years of age.
Adults 18 to 60 years of age will be randomly assigned in a 1:1 ratio to receive either GC3110B or GCFLU Quadrivalent Inj.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC3110B Vaccine Group | Experimental | Participants randomized to receive a single dose of GC3110B vaccine (Biological: GC3110B vaccine). |
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| GCFLU Quadrivalent Inj. | Active Comparator | Participants randomized to receive a single dose of GCFLU Quadrivalent Inj. vaccine (Biological: GCFLU Quadrivalent Inj. vaccine). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC3110B vaccine | Biological | 0.5mL, Intramuscular |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer Ratios of Antibodies to the GC3110B or GCFLU Quadrivalent Inj. | Geometric mean titers of antibodies will be assessed using the hemagglutination inhibition (HI) assay. | Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Pre-Defined Seroconversion Before and Following Vaccination | Seroconversion is defined as either a pre-vaccination titer <1:10 and a post-vaccination titer ≥ 1: 40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer 21 days after vaccination. | Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| GCFLU Quadrivalent Inj. vaccine | Biological | 0.5mL, Intramuscular |
|
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| Percentage of Participants Achieving Pre-Defined Seroprotection Before and Following Vaccination | Antibodies will be assessed using the hemagglutination inhibition (HI) assay. Seroprotection is defined as a titer ≥1:40 at pre-vaccination and 21 days after vaccination. | Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination) |
| Number and Percentage of Participants Reporting Solicited Adverse Events Following Vaccination | Day 0 to Day 6 |
| Number and Percentage of Participants Reporting Unsolicited Adverse Events Following Vaccination | Day 0 to Day 21 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |