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

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

PHASE3

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-10

Study Completion Date

2017-05-08

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.

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Detailed Description

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

Conditions

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Influenza, Human

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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GC3110A vaccine group

Participants administered a single dose of GC3110A(Quadrivalent Influenza Vaccine).

Group Type EXPERIMENTAL

GC3110A vaccine

Intervention Type BIOLOGICAL

0.5mL, Intramuscular

Interventions

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GC3110A vaccine

0.5mL, Intramuscular

Intervention Type BIOLOGICAL

Other Intervention Names

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GC3110A

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes