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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-20

Study Completion Date

2017-12-22

Brief Summary

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

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Detailed Description

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Healthy adults will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj.. Safety and immunological efficacy will be evaluated.

Conditions

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Influenza, Human

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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GC3114

Pre-filled syringe inj., 0.5ml, Once, IM

Group Type EXPERIMENTAL

GC3114

Intervention Type BIOLOGICAL

High-dose Quadrivalent influenza vaccine

GCFLU Quadrivalent

Pre-filled syringe inj., 0.5ml, Once, IM

Group Type ACTIVE_COMPARATOR

GCFLU Quadrivalent

Intervention Type BIOLOGICAL

Quadrivalent influenza vaccine

Interventions

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GC3114

High-dose Quadrivalent influenza vaccine

Intervention Type BIOLOGICAL

GCFLU Quadrivalent

Quadrivalent influenza vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy adults aged 19-64 years old
* Informed consent form has been signed and dated
* Able to comply with the requirements of the study

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
* Pregnant or lactating women

Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes