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The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG Quadrivalent Seasonal Influenza Vaccine) in healthy infants from 6 months to under 3 years of age(≥ 6 months and < 3 years)
The study is an Randomized, Double-blind, Active controlled Phase III study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IL-YANG FLU Vaccine Prefilled Syringe INJ. | Experimental | Teratect Prefilled Syringe Inj. 0.5mL |
|
| GSK FLU Vaccine Prefilled Syringe INJ. | Active Comparator | Fluarix Tetra Pre-filled Syringe 0.5mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IL-YANG FLU Vaccine Prefilled Syringe INJ. | Biological | Teratect Prefilled Syringe Inj. 0.5mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary immunogenicity endpoints |
| From a pre-vaccination (prior to vaccination with the IP, Visit1) to a post-vaccination (at Day 28 after the last vaccination with the IP) |
| 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) | GMT of HI Antibody Titer Before Vaccination and After Vaccination | Up to Day28(+7) after the last vaccination |
| Geometric Mean Ratio(GMR) | GMR of HI Antibody Titer Before Vaccination and After Vaccination |
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Inclusion Criteria:
Exclusion Criteria:
A history of severe hypersensitivity reactions (e.g., anaphylaxis) to eggs, chicken, and other components of a vaccine including those derived from chicken
A history of influenza vaccination within 6 months prior to screening
Immuno dysfunction including immunodeficiency diseases or a family history thereof
A history of Guillain-Barre syndrome
Down's syndrome or cytogenetic disorders
Severe chronic diseases (e.g., cardiovascular diseases excluding controlled hypertension, respiratory diseases with respiratory failure, metabolic diseases, renal dysfunction, hemoglobinopathy, etc.) that, in the opinion of investigator, preclude a subject's participation in the study
Risk of serious bleeding from an IM injection such as hemophilia patients or those on anticoagulants
Acute fever with body temperature exceeding 38.0℃ within 72 hours prior to vaccination with the IP
Vaccinated with other vaccines within 28 days prior to screening
Received immunosuppressants or immune-modifying drugs within 3 months prior to screening
â‘ Azathioprine, cyclosporin, interferon, granulocyte colony-stimulating factor (G-CSF), tacrolimus, everolimus, sirolimus, etc.
② Use of high-dose corticosteroids (e.g., continued use of prednisolone at a dose of ≥2 mg/kg/day in subjects weighing <10 kg for 14 days or longer or at a dose of ≥20 mg/day in subjects weighing ≥10 kg for 14 days or longer). However, inhaled, intranasal, or topical corticosteroids are permitted regardless of their dose.
Prior use of immunoglobulin or blood products within 3 months prior to screening or their anticipated use during the study
Took antipyretics, analgesics, or non-steroidal anti-inflammatory drugs (NSAIDs) within 4 hours prior to vaccination with the IP
Participated in another clinical study within 6 months prior to screening
Determined ineligible based on other clinically significant medical or psychiatric findings by the investigator
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University ANSAN Hospital | Ansan-si | Gyeonnggi-do | 15355 | South Korea | ||
| The Catholic University of Korea, Bucheon St. Mary's Hospital |
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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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| Fluarix Tetra Pre-filled Syringe | Biological | Fluarix Tetra Pre-filled Syringe 0.5mL |
|
| Up to Day28(+7) after the last vaccination |
| Bucheon-si |
| Gyeonnggi-do |
| 15355 |
| South Korea |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |