A Phase 3 interventional study of GC3102C and GC FLU inj. in Prophylaxis Against Influenza, sponsored by Green Cross Corporation. Completed. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-15.
Sponsored by Green Cross Corporation · Phase 3, Interventional, and Prevention
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
Green Cross Corporation is the lead sponsor of 61 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Influneza vaccine, single-dose vial
Biological: GC FLU inj.
Influneza vaccine, multi-dose vial
Biological: GC3102C
a single dose (0.5 mL) intramuscularly on the deltoid muscle
a single dose (0.5 mL) intramuscularly on the deltoid muscle
GMT, using the Hemagglutination inhibition(HI) antibody titer
Time frame: Day 21
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
No study locations are listed for this record.
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Green Cross Corporation