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

Green Cross Corporation105 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

105

Conditions

Influenza, Human

Interventions

GC3114BIOLOGICAL

High-dose Quadrivalent influenza vaccine

GCFLU QuadrivalentBIOLOGICAL

Quadrivalent influenza vaccine

Eligibility

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Korea University Guro Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Adverse Event

Solicited/Unsolicited Adverse Event

Time frame: for 7 days from Day0/during study period

Secondary Outcomes

Percentage of participants achieving pre-defined Seroconversion Before and following vaccination

Seroconversion rate (SCR)

Time frame: Day 0 and Day 28

Percentage of participants achieving pre-defined Seroprotection Before and following vaccination

Seroprotection rate (SPR)

Time frame: Day 0 and Day 28

Geometric Mean Titer of Antibodies to the Investigational Product Before and Following vaccination

Geometric Mean Titer(GMT)

Time frame: Day 0 and Day 28

Geometric Mean Ratio of Antibodies to the Investigational Product Before and Following vaccination

Geometric Mean Ratio(GMR)

Time frame: Day 0 and Day 28

Data from ClinicalTrials.gov

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