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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT01750814
First received: December 12, 2012
Last updated: July 8, 2013
Last verified: July 2013

December 12, 2012
July 8, 2013
June 2013
July 2013   (final data collection date for primary outcome measure)
GMT, using the Hemagglutination inhibition(HI) antibody titer [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01750814 on ClinicalTrials.gov Archive Site
  • Rate of subjects achieving seroconversion [ Time Frame: Day 0 , Day 21 ] [ Designated as safety issue: No ]
  • Rate of subjects achieving seroprotection [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
  • Number of Participants Reporting a Solicited Adverse Events After Vaccination [ Time Frame: Day 6 ] [ Designated as safety issue: Yes ]
  • Number of Participants Reporting a Unsolicited Adverse Events After Vaccination [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
To Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC3102C' Administered Intramuscularly in Healthy Adults
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Prophylaxis Against Influenza
  • Biological: GC3102C
  • Biological: GC FLU inj.
  • Active Comparator: GC FLU inj.
    Intervention: Biological: GC FLU inj.
  • Experimental: GC3102C
    Intervention: Biological: GC3102C
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01750814
GC3102C_P3
No
Green Cross Corporation
Green Cross Corporation
Not Provided
Not Provided
Green Cross Corporation
July 2013

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