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A Multicenter, Double-blind, Parallel, Non-inferiority, Phase III Study

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: NCT02658409
Recruitment Status : Unknown
Verified January 2016 by Green Cross Corporation.
Recruitment status was:  Active, not recruiting
First Posted : January 18, 2016
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation

Brief Summary:
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study.

Condition or disease Intervention/treatment Phase
Influenza Biological: GC3106(quadrivalent cell-culture based influenza vaccine) Biological: Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine) Phase 3

Detailed Description:
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study to Investigate the Efficacy (Immunogenicity) and Safety of GC3106 (quadrivalent cell-culture based influenza vaccine) after Intramuscular Administration in Healthy Subjects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study to Investigate the Efficacy (Immunogenicity) and Safety of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)
Study Start Date : November 2015
Actual Primary Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: GC3106(quadrivalent)
0.5ml, intramuscular, a single dosing
Biological: GC3106(quadrivalent cell-culture based influenza vaccine)
GC3106(quadrivalent),0.5ml, intramuscular, a single dosing at Day 1
Other Name: GC3106

Active Comparator: Fluarix™tetra Syringe Inj.(Quadrivalent)
0.5ml,intramuscular,a single dosing
Biological: Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine)
Fluarix™tetra Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1
Other Name: Fluarix™tetra Syringe Inj.




Primary Outcome Measures :
  1. The effect of the vaccination after 21 days of hemagglutination inhibition antibody (HI antibody) titer was measured through the GMT ratio [ Time Frame: Day 21 post vaccination ]
    (GMT control drug/ GMT test drug)

  2. The effect of the vaccination after 21 days of hemagglutination inhibition antibody (HI antibody) titer was measured through the difference between the SCRs [ Time Frame: Day 21 post vaccination ]
    (SCR control drug- SPR test drug)

  3. Solicited adverse events: Day 0~Day 6 [ Time Frame: Day 0~Day 6 ]
  4. Unsolicited adverse events: Day 0~Day 21 [ Time Frame: Day 0~Day 21 ]

Secondary Outcome Measures :
  1. Rate of subjects achieving seroconversion, defined as post vaccination HI antibody titers [ Time Frame: 21 days after vaccination ]
  2. Rate of subjects achieving seroprotection, defined as post vaccination HI antibody titers [ Time Frame: 21 days after vaccination ]
  3. Vital sign and physical examination [ Time Frame: For 180 days after Visit 1 ]
  4. For 180 days after Visit 1, serious adverse events were presented with the results. [ Time Frame: For 180 days after Visit 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Given written informed consent
  • Healthy Korean adults (age: between over 19)
  • Women of childbearing age with negative Urine hCG in screening visit

Exclusion Criteria:

  • Subjects unable to communicate (illiterate or who cannot understand the questionnaire and/or the study subject diary)
  • Subjects participating in another clinical study or has participated in a clinical study in the last 30 days (the participation should be based on the final dose of the investigational drug)
  • Subjects with impaired immune functions that include immune deficiency diseases
  • Subjects with a history of Guillain-Barre syndrome
  • Hemophilia patients at risk of serious bleeding with intramuscular injection or who had taken an anticoagulant
  • Subjects with symptoms of active infection or who had higher than 38.0℃ fever before the investigational product administration
  • Subjects to be planned to have a surgery in the study duration or subject who the investigator decides exception because of a clinical significant chronic or malignant disease or medical history to interrupt the study procedure
  • Subjects with erythema and/or a tattoo in the injection site of the scheduled investigational product (the deltoid muscle) that is hard to identify the topical toxicity
  • Subjects with a history of allergic reaction to eggs or chicken, the vaccine components, and/or Formaldehyed, Gentamicin and Sodium Deoxychloate
  • Subjects who had been administered the influenza vaccine 6 months before the scheduled vaccination of the investigational product
  • Subjects who had been vaccinated with another vaccine within 30 days before the investigational product administration or had a scheduled vaccination during the clinical study period
  • Subjects who had received an immunosuppressant, immunity-modifying drug, cytotoxic chemotherapy that can affect his or her immune system, or radiation therapy within 3 months before the investigational product administration
  • Subjects receiving systemic steroids (more than 20 mg/day of prednisolone administered everyday over 14 days or more than 700 mg of a cumulative dose during the same period of time) within 3 months before the administration (Day 1) of the investigational product (topical ointments, eye drops, inhalants or intranasally/intramuscularly administered drugs, or topically applied drugs such as ligaments; unless administered every other day over 14 days)
  • Subjects who had received immunoglobulin or a blood-derived product within 3 months before being vaccinated with the investigational product or is scheduled to receive those products during the clinical study period
  • Pregnant women, nursing mothers, or women of childbearing age who do not perform adequate contraception (using a condom, diaphragm, IUD, or hormonal contraception 21 days before vaccination with the investigational product or whose male partner had undergone a vasectomy)

Subjects who have other clinically significant medical or psychiatric examination findings deemed by the investigator to make them ineligible for participation in this clinical study


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): NCT02658409


Locations
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Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Green Cross Corporation
Investigators
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Study Director: Lee Jin Su, M.D Inha University Hospital
Study Director: Choi Won Seck, M.D Korea University
Study Director: Lee Ja Cob Hallym Univ. Medical Center
Study Director: Woo Heong Jung Hallym Univ. Medical Center
Study Director: Wi Sung Heon St. Vincent's Hospital-Manhattan
Study Director: Jeong Suk In Chonnam Natinal University Hospital
Study Director: Kim Sin Woo Kyungpook National University Hospital
Study Director: Kim Tae Hyung Soon Chun Hyang Univ. Hospital
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Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT02658409    
Other Study ID Numbers: GC3106_AD_P3
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: January 2016
Keywords provided by Green Cross Corporation:
CCIV
quadrivalent cell-culture based influenza vaccine
Influenza vaccine
Vaccination
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs