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

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03357263
Recruitment Status : Completed
First Posted : November 29, 2017
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation

November 24, 2017
November 29, 2017
November 19, 2018
November 20, 2017
December 22, 2017   (Final data collection date for primary outcome measure)
Adverse Event [ Time Frame: for 7 days from Day0/during study period ]
Solicited/Unsolicited Adverse Event
Same as current
Complete list of historical versions of study NCT03357263 on ClinicalTrials.gov Archive Site
  • Percentage of participants achieving pre-defined Seroconversion Before and following vaccination [ Time Frame: Day 0 and Day 21 ]
    Seroconversion rate (SCR)
  • Percentage of participants achieving pre-defined Seroprotection Before and following vaccination [ Time Frame: Day 0 and Day 21 ]
    Seroprotection rate (SPR)
  • 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)
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3114 in Healthy Adults
Randomized, Single-Blind, Active Comparator-controlled Study to Evaluate the Safety and Immunological Efficacy of GC3114 in Healthy Adults.
Healthy adults will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Influenza, Human
  • Biological: GC3114
    High-dose Quadrivalent influenza vaccine
  • Biological: GCFLU Quadrivalent
    Quadrivalent influenza vaccine
  • Experimental: GC3114
    Pre-filled syringe inj., 0.5ml, Once, IM
    Intervention: Biological: GC3114
  • Active Comparator: GCFLU Quadrivalent
    Pre-filled syringe inj., 0.5ml, Once, IM
    Intervention: Biological: GCFLU Quadrivalent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
Same as current
December 22, 2017
December 22, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
19 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT03357263
GC3114_P1
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Green Cross Corporation
Green Cross Corporation
Not Provided
Principal Investigator: Woo Joo KIm, M.D, Ph.D Korea University Guro Hospital
Green Cross Corporation
November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP