A Study to Evaluate Efficacy and Safety of GC3110B in Healthy Adults

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 GC3110B versus GCFLU Quadrivalent Inj. among healthy adults in 18 to 60 years of age.

Detailed Description
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Adults 18 to 60 years of age will be randomly assigned in a 1:1 ratio to receive either GC3110B or GCFLU Quadrivalent Inj.

Official Title
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A Randomized, Double-Blind, Multicenter Study to Compare the Immunological Efficacy and Safety of GC3110B With GCFLU Quadrivalent Inj. Administered Intramuscularly in Healthy Adults

Conditions
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Influenza, Human

Intervention / Treatment
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* Biological: GC3110B vaccine
* Biological: GCFLU Quadrivalent Inj. vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults aged 18 to 60 years 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-Barré syndrome 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: 18 Years
Maximum Age: 60 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GC3110B Vaccine Group<br>Participants randomized to receive a single dose of GC3110B vaccine (Biological: GC3110B vaccine). | Biological: GC3110B vaccine<br>* 0.5mL, Intramuscular<br>* Other names: GC3110B;|
| Active Comparator: GCFLU Quadrivalent Inj.<br>Participants randomized to receive a single dose of GCFLU Quadrivalent Inj. vaccine (Biological: GCFLU Quadrivalent Inj. vaccine). | Biological: GCFLU Quadrivalent Inj. vaccine<br>* 0.5mL, Intramuscular<br>* Other names: GCFLU Quadrivalent Inj.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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 | 

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