Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Healthy adults will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..
Healthy adults will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj.. Safety and immunological efficacy will be evaluated.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC3114 | Experimental | Pre-filled syringe inj., 0.5ml, Once, IM |
|
| GCFLU Quadrivalent | Active Comparator | Pre-filled syringe inj., 0.5ml, Once, IM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC3114 | Biological | High-dose Quadrivalent influenza vaccine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | Solicited/Unsolicited Adverse Event | for 7 days from Day0/during study period |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants achieving pre-defined Seroconversion Before and following vaccination | Seroconversion rate (SCR) | Day 0 and Day 21 |
| Percentage of participants achieving pre-defined Seroprotection Before and following vaccination |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Woo Joo KIm, M.D, Ph.D | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31377075 | Derived | Noh JY, Jang YS, Lee SN, Choi MJ, Yoon JG, Yu DH, Song JY, Cheong HJ, Kim WJ. Randomized, single-blind, active-controlled phase I clinical trial to evaluate the immunogenicity and safety of GC3114 (high-dose, quadrivalent influenza vaccine) in healthy adults. Vaccine. 2019 Aug 23;37(36):5171-5176. doi: 10.1016/j.vaccine.2019.07.076. Epub 2019 Jul 31. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| GCFLU Quadrivalent |
| Biological |
Quadrivalent influenza vaccine |
|
Seroprotection rate (SPR)
| Day 0 and Day 21 |
| Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the Investigational Product Before and Following vaccination | Geometric Mean Titer(GMT), Geometric Mean Titer(GMT) | Day 0 and Day 21 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |