To Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC3102C' Administered Intramuscularly 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. Identifier: NCT01750814
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : January 15, 2016
Information provided by (Responsible Party):
Green Cross Corporation

Brief Summary:
The primary objective is to demonstrate the immunological non-inferiority between GC3102C and GC FLU inj. influenza vaccines by assessing geometric mean titers(GMTs) in healthy adults

Condition or disease Intervention/treatment Phase
Prophylaxis Against Influenza Biological: GC3102C Biological: GC FLU inj. Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase III, Randomized, Double-blind, Multi-center Study to Compare the Immunological Efficacy and Safety of GC3102C With GC FLU Inj. Administered Intramuscularly in Healthy Adults
Study Start Date : June 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: GC FLU inj.
Influneza vaccine, single-dose vial
Biological: GC FLU inj.
a single dose (0.5 mL) intramuscularly on the deltoid muscle
Experimental: GC3102C
Influneza vaccine, multi-dose vial
Biological: GC3102C
a single dose (0.5 mL) intramuscularly on the deltoid muscle

Primary Outcome Measures :
  1. GMT, using the Hemagglutination inhibition(HI) antibody titer [ Time Frame: Day 21 ]

Secondary Outcome Measures :
  1. Rate of subjects achieving seroconversion [ Time Frame: Day 0 , Day 21 ]
  2. Rate of subjects achieving seroprotection [ Time Frame: Day 21 ]
  3. Number of Participants Reporting a Solicited Adverse Events After Vaccination [ Time Frame: Day 6 ]
  4. Number of Participants Reporting a Unsolicited Adverse Events After Vaccination [ Time Frame: Day 21 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy adults, 18 to <60 years old
  • Subjets willing to provide written informed consent and able to comply with the requirements for the study

Exclusion Criteria:

  • Subjects with a history of hypersensitivity, especially anaphylactic reactions to egg, egg proteins, chicken or components of vaccine such as gentamicin, gelatin, and arginine
  • Subjects with a history of Guillain-Barré syndrome
  • Subjects with severe chronic diseases (e.g., cardiovascular diseases without controllable hypertension, hemoglobinopathy, respiratory, metabolic, and renal disorders) who are considered by the investigator to be ineligible for the study
  • Subjects previously treated with anti-coagulant therapy or hemophiliac patients who may be at risk of severe hemorrhage after an intramuscular injection
  • Subjects who have had an acute febrile (at least 38.0°C) episode at some time during the 72 hours before enrollment
  • Subjects who have received a vaccination within 7 days before enrollment or who are scheduled for another vaccination (excluding the study vaccine) during the study
  • Immunocompromised subjects with immunodeficiency diseases or those who are receiving immunosuppressive or immunomodulatory therapy, e.g., azathioprine, cyclosporin, interferon, granulocyte-colony stimulating factor, tacrolimus, everolimus, sirolimus
  • Subjects who have received high-dose corticosteroids in the 3 months before vaccination or who will be administered a cumulative dose of 700 mg of corticosteroids during the study. Inhaled, intranasal, and local application of corticosteroids is permitted, regardless of dosage, and corticosteroids such as prednisolone at a maximum dose of 15 mg/day are allowed
  • Subjects who have been administered immunoglobulins or blood-derived products 3 months before enrollment or who are scheduled for the administration during the study
  • Subjects who have received an influenza vaccine within 6 months of enrollment
  • A female subject who is pregnant or who is breast-feeding. Subjects of childbearing potential without an appropriate contraceptive measure within 30 days before enrollment and who do not agree to use a clinically acceptable method of birth control during the study (e.g., oral contraceptives, condom, diaphragm or intrauterine device, or vasectomy of male partner)
  • Subjects who have participated in any other clinical trials within 30 days of the administration of the study vaccine
  • Individuals with other clinically significant medical or psychological condition who are considered by the investigator to be ineligible for the study

Responsible Party: Green Cross Corporation Identifier: NCT01750814     History of Changes
Other Study ID Numbers: GC3102C_P3
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016