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

November 15, 2018 updated by: Green Cross Corporation

Randomized, Single-Blind, Active Comparator-controlled Study to Evaluate the Safety and Immunological Efficacy of GC3114 in Healthy Adults.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GC3114
Pre-filled syringe inj., 0.5ml, Once, IM
Biological: GC3114
High-dose Quadrivalent influenza vaccine
Active Comparator: GCFLU Quadrivalent
Pre-filled syringe inj., 0.5ml, Once, IM
Biological: GCFLU Quadrivalent
Quadrivalent influenza vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Event
Time Frame: for 7 days from Day0/during study period
Solicited/Unsolicited Adverse Event
for 7 days from Day0/during study period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants achieving pre-defined Seroconversion Before and following vaccination
Time Frame: Day 0 and Day 21
Seroconversion rate (SCR)
Day 0 and Day 21
Percentage of participants achieving pre-defined Seroprotection Before and following vaccination
Time Frame: Day 0 and Day 21
Seroprotection rate (SPR)
Day 0 and Day 21
Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the Investigational Product Before and Following vaccination
Time Frame: Day 0 and Day 21
Geometric Mean Titer(GMT), Geometric Mean Titer(GMT)
Day 0 and Day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Green Cross Corporation

Investigators

  • Principal Investigator: Woo Joo KIm, M.D, Ph.D, Korea University Guro Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2017

Primary Completion (Actual)

December 22, 2017

Study Completion (Actual)

December 22, 2017

Study Registration Dates

First Submitted

November 24, 2017

First Submitted That Met QC Criteria

November 24, 2017

First Posted (Actual)

November 29, 2017

Study Record Updates

Last Update Posted (Actual)

November 19, 2018

Last Update Submitted That Met QC Criteria

November 15, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC3114_P1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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