ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03657719
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation

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

Condition or disease Intervention/treatment Phase
Influenza, Human Biological: GC3114 Biological: GCFLU Quadrivalent Phase 2

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  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Part 1 : Single group, Part2 : Parallel group
Masking: Double (Participant, Investigator)
Masking Description: Part 1 : Open label, Part 2 : Double blind
Primary Purpose: Prevention
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
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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




Primary Outcome Measures :
  1. Adverse Event [ Time Frame: for 7 days from Day0/during study period ]
    Solicited/Unsolicited Adverse Event


Secondary Outcome Measures :
  1. Percentage of participants achieving pre-defined Seroconversion Before and following vaccination [ Time Frame: Day 0 and Day 28 ]
    Seroconversion rate (SCR)

  2. Percentage of participants achieving pre-defined Seroprotection Before and following vaccination [ Time Frame: Day 0 and Day 28 ]
    Seroprotection rate (SPR)

  3. Geometric Mean Titer of Antibodies to the Investigational Product Before and Following vaccination [ Time Frame: Day 0 and Day 28 ]
    Geometric Mean Titer(GMT)

  4. Geometric Mean Ratio of Antibodies to the Investigational Product Before and Following vaccination [ Time Frame: Day 0 and Day 28 ]
    Geometric Mean Ratio(GMR)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657719


Locations
Korea, Republic of
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Contact: Woo Joo Kim, M.D. Ph.D.    +82    wjkim@korea.ac.kr   
Principal Investigator: Woo Joo Kim, M.D. Ph.D.         
Sponsors and Collaborators
Green Cross Corporation
Investigators
Principal Investigator: Woo Joo KIm, M.D, Ph.D Korea University Guro Hospital

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT03657719     History of Changes
Other Study ID Numbers: GC3114_P2
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases