KCT0006127
Completed
未知
Evaluation of immunogenicity of influenza vaccine in children
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Korea University Ansan Hospital
- Enrollment
- 130
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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