None listed
Conditions
Interventions
None listed
Sponsors
Korea University Ansan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy children of 6 months to under 6 years of age : For children under 1 year of age, if the gestation period is more than 37 weeks 2) Those who understand the clinical trial and agree to participate in the clinical trial
Exclusion criteria
Exclusion criteria: 1) Persons suffering from immunodeficiency disease or malignant tumors 2) Those with a history of hypersensitivity during vaccination such as Guillain-Barre syndrome 3) Thrombocytopenia or other clotting disorders that should not be given intramuscular injection 4) Those who have a body temperature exceeding 38°C within 72 hours from the day of inoculation of the investigational drug or suffer from a feverish disease (body temperature exceeding 38°C) on the day of inoculation 5) Those who took the following immunosuppressants/immunomodulators within 3 months of screening (Cyclophophamide, 6-mercaptopurine, azathioprine, methotrexate, steroids, cyclosporine A, rapamycin, leflunomide, etc.) Biological treatments such as metabolites, monoclonal antibodies, anti-lymphocyte serum, etc., radiation therapy, etc. inhaled), intranasal and topical administration of steroids is allowed) 6) Those who received blood products/immunoglobulins within 3 months before the screening test date 7) Those who have been vaccinated against influenza vaccine within 6 months before the screening test date 8) Those who have participated in other clinical trials within 4 weeks before the inoculation date of the investigational drug and have inoculated or taken the investigational drug 9) Persons suffering from severe chronic diseases that make it difficult to participate in clinical trials 10) A person who judges that the investigator is unsuitable for participation in the clinical trial due to other reasons including clinically significant medical or psychiatric finding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Seroprotection rate-After vaccination, calculate the proportion of subjects whose HI titer increased to 1:40 or higher. 2. Seroconversion rate-Calculate the proportion of subjects who satisfy one of the following. -If HI titer <1:10 before vaccination, subjects with HI titer = 1:40 after vaccination 3. Geometric Mean Ratio-Calculate the geometric mean increase rate of HI titer before and after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Seroprotection rate-After vaccination, calculate the proportion of subjects whose HI titer increased to 1:40 or higher. 2. Seroconversion rate-Calculate the proportion of subjects who satisfy one of the following. -If HI titer <1:10 before vaccination, subjects with HI titer = 1:40 after vaccination 3. Geometric Mean Ratio-Calculate the geometric mean increase rate of HI titer before and after vaccination | — |
Countries
Korea, Republic of
Contacts
Public Contactinkyoung choi
Korea University Ansan Hospital
Outcome results
None listed