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A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC3110A(Quadrivalent) | Experimental | 0.5ml, intramuscular, a single dosing |
|
| GC Flu (Trivalent) | Active Comparator | 0.5ml,intramuscular,a single dosing |
|
| GC3110A(Trivalent) | Active Comparator | 0.5ml,intramuscular,a single dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC3110A(Quadrivalent) | Biological | GC3110A(Quadrivalent), 0.5ml, intramuscular, a single dosing at Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| GMT rate of HI(Hemagglutination Inhibition) antibody for each strain | GMT (Active comparator) / GMT(Experimental) | Day 21 post vaccination |
| Solicited adverse events following 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 | Day0 up to 21 Day post vaccination |
| Unsolicited adverse events following vaccination | It can be estimated by Toxicity Grading Scale for healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials | Day0 up to 21 Day post vaccination |
| SCR rate of HI(Hemagglutination Inhibition) antibody for each strain | Difference of SCR (Experimental and Active comparator) | Day 21 post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| SCR rate of HI(Hemagglutination Inhibition) antibody for each strain | Day0 up to 21 Day post vaccination | |
| SPR rate of HI(Hemagglutination Inhibition) antibody | Day 21 post vaccination | |
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Criteria: Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee Jin Su, M.D | Inha University Hospital | Study Director |
| Choi Won Seck, M.D | Korea University Ansan Hospital | Study Director |
| Lee Ja Cob | Hallym Univ. Medical Center | Study Director |
| Woo Heong Jung | Hallym Univ. Medical Center | Study Director |
| Wi Sung Heon | St Vincent's Hospital | Study Director |
| Jeong Suk In | Chonnam Natinal University Hospital | Study Director |
| Kim Sin Woo | Kyungpook National University Hospital | Study Director |
| Kim Tae Hyung | Soon Chun Hyang Univ. Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| GC Flu(Trivalent) | Biological | GC Flu Pre-filled Syringe Inj.(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1 |
|
|
| GC3110A(Trivalent) | Biological | GC3110A(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1 |
|
|
| GMT rate of HI(Hemagglutination Inhibition) antibody for each strain |
| Day 21 post vaccination |
| Abnormalities in physical examination, Vital signs, clinical laboratory tests | Day 21 post vaccination |
| SAE | Day 180 post vaccination |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |