KCT0006127已完成未知
Evaluation of immunogenicity of influenza vaccine in children
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational Study
入排标准
- 年龄范围
- 6??(Month) 至 5?(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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