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

January 3, 2019 updated by: Green Cross Corporation

Open-labeled(Part 1), Single-group(Part 2), Randomized(Part 2), Double-blind(Part 2), Active-controlled(Part 2) Pharse II Clinical Trial to Evaluate Safety and Efficacy(Immunogenicity) of GC3114 in Elderly Healthy Subjects

Elderly healthy subjects 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

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

Enrollment (Actual)

105

Phase

  • Phase 2

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Double

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: 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 28
Seroconversion rate (SCR)
Day 0 and Day 28
Percentage of participants achieving pre-defined Seroprotection Before and following vaccination
Time Frame: Day 0 and Day 28
Seroprotection rate (SPR)
Day 0 and Day 28
Geometric Mean Titer of Antibodies to the Investigational Product Before and Following vaccination
Time Frame: Day 0 and Day 28
Geometric Mean Titer(GMT)
Day 0 and Day 28
Geometric Mean Ratio of Antibodies to the Investigational Product Before and Following vaccination
Time Frame: Day 0 and Day 28
Geometric Mean Ratio(GMR)
Day 0 and Day 28

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

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)

October 1, 2018

Primary Completion (Actual)

December 13, 2018

Study Completion (Actual)

December 13, 2018

Study Registration Dates

First Submitted

August 27, 2018

First Submitted That Met QC Criteria

September 1, 2018

First Posted (Actual)

September 5, 2018

Study Record Updates

Last Update Posted (Actual)

January 4, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC3114_P2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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