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

May 24, 2017 updated by: Green Cross Corporation

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

The purpose of this study is to evaluate immunological efficacy and safety of GC3110A among healthy adults over 65 years of age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adults over 65 years of age will be once administered GC3110A(Quadrivalent influenza vaccine).

Study Type

Interventional

Enrollment (Actual)

274

Phase

  • Phase 3

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

  • Korea, Republic of
      • Daejeon, Korea, Republic of
        • The Catholic Univ. of Korea Daejeon St.Mary's Hospital
      • Gyeonggi-do, Korea, Republic of
        • Soon Chun Hyang University Bucheon Hospital
      • Gyeonggi-do, Korea, Republic of
        • The Catholic Univ.of Korea Bucheon St.Mary's Hospital
      • Gyeonggi-do, Korea, Republic of
        • The Catholic Univ.of Korea Uijeongbu St.Mary's Hospital
      • Seoul, Korea, Republic of
        • Kyunghee University Medical Center
      • Seoul, Korea, Republic of
        • Ewha Woman's University Mokdong Hospital
      • Seoul, Korea, Republic of
        • Soon Chun Hyang University Seoul Hospital
      • Seoul, Korea, Republic of
        • The Catholic Univ. of Korea Incheon St.Mary's Hospital
      • Seoul, Korea, Republic of
        • The Catholic Univ.of Korea Seoul St.Mary's Hospital
      • Seoul, Korea, Republic of
        • The Catholic Univ.of Korea Yeouido St.Mary's Hospital

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

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GC3110A vaccine group
Participants administered a single dose of GC3110A(Quadrivalent Influenza Vaccine).
Biological: GC3110A vaccine
0.5mL, Intramuscular
Other Names:
  • GC3110A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination
Time Frame: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination
Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination
Time Frame: Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination
Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the GC3110A Before and Following Vaccination
Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)

Collaborators and Investigators

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

Sponsor

Green Cross Corporation

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 10, 2016

Primary Completion (Actual)

December 2, 2016

Study Completion (Actual)

May 8, 2017

Study Registration Dates

First Submitted

September 26, 2016

First Submitted That Met QC Criteria

September 26, 2016

First Posted (Estimate)

September 28, 2016

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC3110A_ED_P3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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