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

Primary Purpose

Influenza, Human

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GC3110A vaccine
Sponsored by
Green Cross Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza, Human focused on measuring Quadrivalent Influenza Vaccines

Eligibility Criteria

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

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

Sites / Locations

  • The Catholic Univ. of Korea Daejeon St.Mary's Hospital
  • Soon Chun Hyang University Bucheon Hospital
  • The Catholic Univ.of Korea Bucheon St.Mary's Hospital
  • The Catholic Univ.of Korea Uijeongbu St.Mary's Hospital
  • EWHA woman's university mokdong hospital
  • KyungHee University Medical Center
  • Soon Chun Hyang University Seoul Hospital
  • The Catholic Univ. of Korea Incheon St.Mary's Hospital
  • The Catholic Univ.of Korea Seoul St.Mary's Hospital
  • The Catholic Univ.of Korea Yeouido St.Mary's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GC3110A vaccine group

Arm Description

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

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination
Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination
Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination
Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination

Secondary Outcome Measures

Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the GC3110A Before and Following Vaccination
Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the GC3110A Before and Following Vaccination

Full Information

First Posted
September 26, 2016
Last Updated
May 24, 2017
Sponsor
Green Cross Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02917304
Brief Title
A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Subjects Aged 65 Years and Older
Official Title
A Multicenter, Open-label, Single Arm Study to Evaluate the Immunological Efficacy and Safety of GC3110A. Administered Intramuscularly in Healthy Subjects Aged 65 Years and Older
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 10, 2016 (Actual)
Primary Completion Date
December 2, 2016 (Actual)
Study Completion Date
May 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Cross Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate immunological efficacy and safety of GC3110A among healthy adults over 65 years of age.
Detailed Description
Adults over 65 years of age will be once administered GC3110A(Quadrivalent influenza vaccine).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human
Keywords
Quadrivalent Influenza Vaccines

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
274 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GC3110A vaccine group
Arm Type
Experimental
Arm Description
Participants administered a single dose of GC3110A(Quadrivalent Influenza Vaccine).
Intervention Type
Biological
Intervention Name(s)
GC3110A vaccine
Other Intervention Name(s)
GC3110A
Intervention Description
0.5mL, Intramuscular
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination
Description
Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination
Time Frame
Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Title
Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination
Description
Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination
Time Frame
Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Secondary Outcome Measure Information:
Title
Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the GC3110A Before and Following Vaccination
Description
Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the GC3110A Before and Following Vaccination
Time Frame
Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
The Catholic Univ. of Korea Daejeon St.Mary's Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Bucheon Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
The Catholic Univ.of Korea Bucheon St.Mary's Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
The Catholic Univ.of Korea Uijeongbu St.Mary's Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
EWHA woman's university mokdong hospital
City
Seoul
Country
Korea, Republic of
Facility Name
KyungHee University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Seoul Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic Univ. of Korea Incheon St.Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic Univ.of Korea Seoul St.Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic Univ.of Korea Yeouido St.Mary's Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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