A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Subjects Aged 65 Years and Older

Study Overview
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Brief Summary
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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.

Detailed Description
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Adults over 65 years of age will be once administered GC3110A(Quadrivalent influenza vaccine).

Official Title
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A Multicenter, Open-label, Single Arm Study to Evaluate the Immunological Efficacy and Safety of GC3110A. Administered Intramuscularly in Healthy Subjects Aged 65 Years and Older

Conditions
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Influenza, Human

Intervention / Treatment
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* Biological: GC3110A vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults aged 65 years and older Informed consent form has been signed and dated Able to comply with the requirements of the study Exclusion Criteria: Known systemic hypersensitivity 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GC3110A vaccine group<br>Participants administered a single dose of GC3110A(Quadrivalent Influenza Vaccine). | Biological: GC3110A vaccine<br>* 0.5mL, Intramuscular<br>* Other names: GC3110A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quadrivalent Influenza Vaccines