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

Green Cross Corporation414 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

414

Conditions

Influenza, Human

Interventions

GC3110B vaccineBIOLOGICAL

0.5mL, Intramuscular

GCFLU Quadrivalent Inj. vaccineBIOLOGICAL

0.5mL, Intramuscular

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)

Secondary Outcomes

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.

Time frame: 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.

Time frame: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)

Number and Percentage of Participants Reporting Solicited Adverse Events Following Vaccination

Time frame: Day 0 to Day 6

Number and Percentage of Participants Reporting Unsolicited Adverse Events Following Vaccination

Time frame: Day 0 to Day 21

Data from ClinicalTrials.gov

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