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
The purpose of this study is to evaluate the immunogenicity and safety of 'IL-YANG Quadrivalent Seasonal Influenza Vaccine' in healthy Korean children and adolescents.
The study is an open-label(Part 1), Single-arm(Part 1), Randomized(Part 2), Double-blind(Part 2), Active comparator(Part 2) Phase III study.
Before initiation of any protocol-specific activities, written informed consent is obtained from each patient and their legally acceptable representatives. Subjects who meet all of the eligibility criteria after screening assessments as specified in the protocol, are randomized into the test group or the comparator group in a ratio of 4 :1 and receive a single dose or two doses of the study vaccine. The investigator perform the efficacy (immunogenicity) and safety assessments throughout the study. Efficacy data are collected at Visit 1 (prior to vaccination) and at the end-of-study visit for efficacy (immunogenicity) assessments, and for safety assessment, subjects and their legally acceptable representatives are instructed to record any treatment-emergent adverse event in Patient Diary cards.
For all randomized subjects, blood sample is obtained prior to vaccination, and the study vaccine 0.5mL is administered. For children aged from 3 years to <9 years of age who have not previously received influenza vaccine, another dose of the study vaccine is administered 4 to 5 weeks after the first dose. Blood samples are collected 4 to 5 weeks after the last dose of the study drug for the assessment of antibody titer. All subjects are followed for 6 months after the last dose of the study drug for the safety assessments, and Month 6 follow-up visit is the end-of-study visit.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IL-YANG Quadrivalent Influenza Vaccine | Experimental | The vaccine contains both B strain (Yamagata, Victoria) |
|
| IL-YANG Flu Vaccine Pre-filled Syringe | Active Comparator | The vaccine contains the B/Yamagata strain and it was approved for commercial sale by Ministry of Food and Drug Safety. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IL-YANG Quadrivalent Influenza Vaccine | Biological | A single 0.5mL dose administrated as an intramuscular injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate against Hemagglutination Inhibition(HI) antibody | Seroconversion rate(a lower bound of 95 CI) ≥ 40% | Up to Day28(+7) after the last vaccination |
| Seroprotection rate against Hemagglutination | Seroprotection rate(a lower bound of 95 CI) ≥ 70% | Up to Day28(+7) after the last vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer(GMT) and Geometric Mean Ratio(GMR) | GMT and GMR of HI Antibody Titer Before Vaccination and After Vaccination | Up to Day28(+7) after the last vaccination |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jin-Han Kang, MD.PhD | The catholic university of Korea, Seoul ST. Marry's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The catholic university of Korea, Seoul ST. Marry's Hospital | Seoul | 06591 | South Korea |
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
| IL-YANG Flu Vaccine Pre-filled Syringe | Biological | A single 0.5mL dose administrated as an intramuscular injection. |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |