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

Primary Purpose

Influenza, Human

Status

Completed

Phase

Phase 1

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

19 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GC3114

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

Geometric Mean Titer(GMT), Geometric Mean Titer(GMT)

Full Information

NCT ID

NCT03357263

First Posted

November 24, 2017

Last Updated

November 15, 2018

Sponsor

Green Cross Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03357263

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

November 20, 2017 (Actual)

Primary Completion Date

December 22, 2017 (Actual)

Study Completion Date

December 22, 2017 (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

5. Study Description

Brief Summary

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

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.

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 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GC3114

Arm Type

Experimental

Arm Description

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

Arm Title

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 21

Title

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

Description

Seroprotection rate (SPR)

Time Frame

Day 0 and Day 21

Title

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

Description

Geometric Mean Titer(GMT), Geometric Mean Titer(GMT)

Time Frame

Day 0 and Day 21

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

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

Plan to Share IPD

Citations:

PubMed Identifier

31377075

Citation

Noh JY, Jang YS, Lee SN, Choi MJ, Yoon JG, Yu DH, Song JY, Cheong HJ, Kim WJ. Randomized, single-blind, active-controlled phase I clinical trial to evaluate the immunogenicity and safety of GC3114 (high-dose, quadrivalent influenza vaccine) in healthy adults. Vaccine. 2019 Aug 23;37(36):5171-5176. doi: 10.1016/j.vaccine.2019.07.076. Epub 2019 Jul 31.

Results Reference

derived

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

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