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
Not provided
Not provided
Part 1 If study subject and legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Form (In the case of study subject less than 7 years of age, written informed consent by study subject's legal guardians), study subjects eligible for participating this trial protocol were assigned to test group and receiving the test drug 1 times or 2 times according to age.
Part 2 If study subject and legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Form(In the case of study subject less than 7 years of age, written informed consent by study subject's legal guardians), the 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 drug 1 times or 2 times according to age as below;
Part 1 If study subject and legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Form (In the case of study subject less than 7 years of age, written informed consent by study subject's legal guardians), study subjects eligible for participating this trial protocol were assigned to test group and receiving the test drug 1 times or 2 times according to age.
The safety data collected during part A will be reviewed by DSMB to evaluate the solicited adverse events for 7 days after each vaccination.
However, if no toxicity higher than grade 3 according to FDA guidance the study was allowed to proceed to Part 2 without DSMB review.
Efficacy and safety assessment methods, and visiting schedule will be the same as Part 2.
Part 2 If study subject and legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Form(In the case of study subject less than 7 years of age, written informed consent by study subject's legal guardians), the 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 drug 1 times or 2 times according to age as below;
Blood samples will be collected at visit 1 for efficacy 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 of doses of 0.25mL or 0.5mL according to age will be intramuscularly injected. However, those who had not been vaccinated with influenza vaccine, aged of over than 6 months to less than 9 years study subjects, 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 1~2, Visit 3~4 and Visit 5~6.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC3110A | Experimental | One injection : 0.5ml or 0.25ml, IM on day 0 Two injection : 0.5ml or 0.25ml, IM on day 0 |
|
| GCFLU Pre-filled Syringe inj. | Active Comparator | One injection : 0.5ml or 0.25ml, IM on day 0 Two injection : 0.5ml or 0.25ml, IM on day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC3110A | Biological | A single 0.5mL dose intramuscular injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of study subjects achieving seroconversion* for HI antibody(seroconversion rate) The percentage of study subjects achieving a post-vaccination HI antibody titer≥1:40 (seroprotection rate) | 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) |
| 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) |
| GMR | GMR (Geometric Mean Ratio) of HI antibody titer before vaccination (Day 0) and after vaccination (Day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| SAEs (VIsit 1 to Day 180) | The presence of the serious adverse events occurred from visit 1 to day 180 | VIsit 1 (Day 0) to Day 180 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jin-han Kang, Dr. | The Catholic Univ. of Korea Seoul St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changwon Fatima Hospital | Changwon | South Korea | ||||
| Keimyung University Dongsan Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29573247 | Derived | Lee J, Lee KY, Kim JH, Kim CS, Eun BW, Kim HM, Kim DH, Hong YJ, Choi YY, Jo DS, Ma SH, Kang JH. Safety and Immunogenicity of an Egg-Cultivated Quadrivalent Inactivated Split-virion Influenza Vaccine (GC3110A) in Healthy Korean Children: a Randomized, Double-blinded, Active-controlled Phase III Study. J Korean Med Sci. 2018 Mar 26;33(13):e100. doi: 10.3346/jkms.2018.33.e100. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| GCFLU Pre-filled Syringe inj. |
| Biological |
A single 0.5mL dose intramuscular injection |
|
| Post-vaccination (Day 28) |
| The solicited adverse events (7 days after vaccination) | The presence of the solicited adverse events occurred during 7 days after vaccination Local reaction: pain, tenderness, erythema/redness, induration/swelling Systemic reaction: fever, sweating, chills, nausea/vomiting, diarrhea, fatigue/malaise, headache, myalgia, arthralgia | Post-vaccination (Day 7) |
| The unsolicited adverse events (28 days after vaccination) | The presence of the unsolicited adverse events occurred during 28 days after the study vaccination | Post-vaccination (Day 28) |
| Daegu |
| South Korea |
| The Catholic Univ. of Korea Daejeon St. Mary's Hospital | Daejeon | South Korea |
| Chonnam National University Hospital | Gwangju | South Korea |
| Inha University Hospital | Incheon | South Korea |
| Chonbuk National University Hospital | Jeonju | South Korea |
| Eulji University Medical Center | Seoul | South Korea |
| Kepco Medical Center | Seoul | South Korea |
| Korea Cancer Center Hospital | Seoul | South Korea |
| The Catholic Univ. of Korea Seoul St. Mary's Hospital | Seoul | South Korea |
| The Catholic Univ. of Korea St. Vincent's Hospital | Suwon | South Korea |
| Wonju Severance Christian Hospital | Wŏnju | South Korea |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided