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

This study is not yet open for participant recruitment.

Verified December 2012 by Green Cross Corporation

Sponsor:

Information provided by (Responsible Party):

Green Cross Corporation

ClinicalTrials.gov Identifier:

NCT01750814

First received: December 12, 2012

Last updated: December 13, 2012

Last verified: December 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	December 12, 2012
Last Updated Date	December 13, 2012
Start Date ^ICMJE	Not Provided
Estimated Primary Completion Date	September 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 13, 2012)	GMT, using the Hemagglutination inhibition(HI) antibody titer [ Time Frame: Day 21 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01750814 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 13, 2012)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	To Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC3102C' Administered Intramuscularly in Healthy Adults
Official Title ^ICMJE	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
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
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Condition ^ICMJE	Prophylaxis Against Influenza
Intervention ^ICMJE	Biological: GC3102C Biological: GC FLU inj.
Study Arm (s)	Active Comparator: GC FLU inj. Intervention: Biological: GC FLU inj. Experimental: GC3102C Intervention: Biological: GC3102C
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	400
Completion Date	Not Provided
Estimated Primary Completion Date	September 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01750814
Other Study ID Numbers ^ICMJE	GC3102C_P3
Has Data Monitoring Committee	No
Responsible Party	Green Cross Corporation
Study Sponsor ^ICMJE	Green Cross Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Green Cross Corporation
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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