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To Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC3102C' Administered Intramuscularly in Healthy Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01750814
First Posted: December 17, 2012
Last Update Posted: January 15, 2016
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.
Information provided by (Responsible Party):
Green Cross Corporation
  Purpose
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 Intervention Phase
Prophylaxis Against Influenza Biological: GC3102C Biological: GC FLU inj. Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Green Cross Corporation:

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

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

Enrollment: 400
Study Start Date: June 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT01750814     History of Changes
Other Study ID Numbers: GC3102C_P3
First Submitted: December 12, 2012
First Posted: December 17, 2012
Last Update Posted: January 15, 2016
Last Verified: January 2016


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