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

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ClinicalTrials.gov Identifier: NCT03357263
Recruitment Status : Completed
First Posted : November 29, 2017
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation

Brief Summary:
Healthy adults 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 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Randomized, Single-Blind, Active Comparator-controlled Study to Evaluate the Safety and Immunological Efficacy of GC3114 in Healthy Adults.
Actual Study Start Date : November 20, 2017
Actual Primary Completion Date : December 22, 2017
Actual Study Completion Date : December 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
Experimental: GC3114
Pre-filled syringe inj., 0.5ml, Once, IM
Biological: GC3114
High-dose Quadrivalent influenza vaccine
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 21 ]
    Seroconversion rate (SCR)

  2. Percentage of participants achieving pre-defined Seroprotection Before and following vaccination [ Time Frame: Day 0 and Day 21 ]
    Seroprotection rate (SPR)

  3. Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the Investigational Product Before and Following vaccination [ Time Frame: Day 0 and Day 21 ]
    Geometric Mean Titer(GMT), Geometric Mean Titer(GMT)



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Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT03357263


Locations
Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
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: NCT03357263     History of Changes
Other Study ID Numbers: GC3114_P1
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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