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

Primary Purpose

Influenza, Human

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

GC3114

GCFLU Quadrivalent

About this trial

This is an interventional prevention trial for Influenza, Human

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GC3114

Active Comparator: GCFLU Quadrivalent

Arm Description

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

Outcomes

Primary Outcome Measures

Adverse Event

Solicited/Unsolicited Adverse Event

Secondary Outcome Measures

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

Seroconversion rate (SCR)

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

Seroprotection rate (SPR)

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

Geometric Mean Titer(GMT)

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

Geometric Mean Ratio(GMR)

Full Information

NCT ID

NCT03657719

First Posted

August 27, 2018

Last Updated

January 3, 2019

Sponsor

Green Cross Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03657719

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

December 13, 2018 (Actual)

Study Completion Date

December 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Green Cross Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Human

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Part 1 : Single group, Part2 : Parallel group

Masking

ParticipantInvestigator

Masking Description

Part 1 : Open label, Part 2 : Double blind

Allocation

Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GC3114

Arm Type

Experimental

Arm Description

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

Arm Title

Active Comparator: GCFLU Quadrivalent

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

GC3114

Intervention Description

High-dose Quadrivalent influenza vaccine

Intervention Type

Biological

Intervention Name(s)

GCFLU Quadrivalent

Intervention Description

Quadrivalent influenza vaccine

Primary Outcome Measure Information:

Title

Adverse Event

Description

Solicited/Unsolicited Adverse Event

Time Frame

for 7 days from Day0/during study period

Secondary Outcome Measure Information:

Title

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

Description

Seroconversion rate (SCR)

Time Frame

Day 0 and Day 28

Title

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

Description

Seroprotection rate (SPR)

Time Frame

Day 0 and Day 28

Title

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

Description

Geometric Mean Titer(GMT)

Time Frame

Day 0 and Day 28

Title

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

Description

Geometric Mean Ratio(GMR)

Time Frame

Day 0 and Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Woo Joo KIm, M.D, Ph.D

Organizational Affiliation

Korea University Guro Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Korea University Guro Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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