A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3114 in Elderly Healthy Subjects

Study Overview
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Brief Summary
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Elderly healthy subjects will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..

Detailed Description
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Elderly healthy subjects will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj.. Safety and immunological efficacy will be evaluated.

Official Title
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Open-labeled(Part 1), Single-group(Part 2), Randomized(Part 2), Double-blind(Part 2), Active-controlled(Part 2) Pharse II Clinical Trial to Evaluate Safety and Efficacy(Immunogenicity) of GC3114 in Elderly Healthy Subjects

Conditions
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Influenza, Human

Intervention / Treatment
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* Biological: GC3114
* Biological: GCFLU Quadrivalent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults aged over 65 years old Informed consent form has been signed and dated Exclusion Criteria: Known systemic hypersensitive to eggs, chicken proteins, or any of the vaccine components Personal history of Guillain-Barre syndrome(GBS) Subjects with severe chronic disease who are considered by investigator to be ineligible for the study Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Part 1 : Single group, Part2 : Parallel group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GC3114<br>Pre-filled syringe inj., 0.5ml, Once, IM | Biological: GC3114<br>* High-dose Quadrivalent influenza vaccine<br>|
| Active Comparator: Active Comparator: GCFLU Quadrivalent<br>Pre-filled syringe inj., 0.5ml, Once, IM | Biological: GCFLU Quadrivalent<br>* Quadrivalent influenza vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event | Solicited/Unsolicited Adverse Event | for 7 days from Day0/during study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants achieving pre-defined Seroconversion Before and following vaccination | Seroconversion rate (SCR) | Day 0 and Day 28 | 
| Percentage of participants achieving pre-defined Seroprotection Before and following vaccination | Seroprotection rate (SPR) | Day 0 and Day 28 | 
| Geometric Mean Titer of Antibodies to the Investigational Product Before and Following vaccination | Geometric Mean Titer(GMT) | Day 0 and Day 28 | 
| Geometric Mean Ratio of Antibodies to the Investigational Product Before and Following vaccination | Geometric Mean Ratio(GMR) | Day 0 and Day 28 |