Korea University Guro Hospital
Seoul, South Korea
NCT Number: NCT02352584
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III
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Notify Me19 year and older
All sexes
Interventional
Phase 3
Seoul, South Korea
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Study to Investigate the Efficacy(Immunogenicity) and Safety of GC3110A(Quadrivalent Influenza Vaccine) After Intramuscular Administration in Healthy Subjects
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Criteria: Inclusion Criteria:
Exclusion criteria
GC3110A(Quadrivalent), 0.5ml, intramuscular, a single dosing at Day 1
Other names: GC3110A
GC Flu Pre-filled Syringe Inj.(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1
Other names: GC Flu Pre-filled Syringe Inj.
GC3110A(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1
Other names: GC3110A
Time frame: Day 21 post vaccination
GMT (Active comparator) / GMT(Experimental)
Time frame: Day0 up to 21 Day post vaccination
Solicited injection site reactions: Pain, Tenderness, Erythema, Redness, Induration, and Swelling; Solicited systemic reactions: Fever, Sweating, Chill, Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, Arthralgia
Time frame: Day0 up to 21 Day post vaccination
It can be estimated by Toxicity Grading Scale for healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
Time frame: Day 21 post vaccination
Difference of SCR (Experimental and Active comparator)
Time frame: Day0 up to 21 Day post vaccination
Time frame: Day 21 post vaccination
Time frame: Day 21 post vaccination
Time frame: Day 21 post vaccination
Time frame: Day 180 post vaccination
Green Cross Corporation
Industry
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Study to Investigate the Efficacy(Immunogenicity) and Safety of GC3110A(Quadrivalent Influenza Vaccine)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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