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If study subject's legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Formed, study subjects eligible for participating this trial protocol were assigned to test group or control group with the ratio of 4:1 and receiving the test or control drug 1 time or 2 times.
The investigator will evaluate the efficacy and safety of the test product while clinical trial.
Blood samples will be collected at visit 1 and visit 5 for immunogenicity evaluation. The study subject and their legal guardians will be educated to daily record AEs after vaccination on the patient diary to evaluate the safety.
At visit1, blood samples will be collected from randomized study subjects and investigational drug will be intramuscularly injected. However, those who had not been vaccinated with influenza vaccine, will re-visit and have the 2nd vaccination, 4~5 weeks after the 1st vaccination.
After 4~5 weeks since last vaccination, study subjects will visit and blood sample will be collected. And the serious adverse events occurred during 180 days after the final vaccination will be checked through the telephone visit.
The study subjects with 1 dose of vaccine will have 4 visits including Visit 1~2 and Visit 5~6. The study subjects with 2 dose of vaccine will have 6 visits including Visit 3~4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC3110A | Experimental | One injection: Day 0 Two injection: Day 0 and Day 28 |
|
| GCFLU Pre-filled syringe inj. | Active Comparator | One injection: Day 0 Two injection: Day 0 and Day 28 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC3110A | Biological | A single 0.5mL dose intramuscular injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate for HI antibody after final injection | the percentage of study subjects with a pre-vaccination (Day 0) HI titer<1:10 and post-vaccination (Day 28) HI antibody titer≥1:40(Case1), or the percentage of study subjects with a pre-vaccination HI antibody titer≥1:10 and a minimum four-fold rise in post-vaccination HI antibody titer(Case 2) | Post-vaccination (Day 28 or 56) |
| Seroprotection rate for HI antibody after final injection | Post-vaccination (Day 28 or 56) |
| Measure | Description | Time Frame |
|---|---|---|
| GMT | GMT(Geometric Mean Titer) of HI antibody titer before vaccination(Day 0) and after vaccination (Day 28) | Post-vaccination (Day 28 or 56) |
| GMR | GMR(Geometric Mean Ratio) of HI antibody titer before vaccination(Day 0) and after vaccination (Day 28) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Han-A Cha | Contact | +82-260-1936 | hacha@greencross.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic Univ.of Korea Seoul St.Mary's Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33736920 | Derived | Choi UY, Kim KH, Lee KY, Kim JH, Kim CS, Eun BW, Kim HM, Kim DH, Song SE, Jo DS, Lee J, Ma SH, Kim KN, Kang JH. Active-controlled phase III study of an egg-cultivated quadrivalent inactivated split-virion influenza vaccine (GC3110A) in healthy Korean children aged 6-35 months. Vaccine. 2021 Apr 8;39(15):2103-2109. doi: 10.1016/j.vaccine.2021.03.005. Epub 2021 Mar 16. |
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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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| GCFLU Pre-filled syringe inj. |
| Biological |
A single 0.25mL dose intramuscular injection |
|
| Post-vaccination (Day 28 or 56) |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |