EUCTR2014-004131-40-Outside-EU/EEA进行中（未招募）不适用
A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in a paediatric population aged greater than or equal to 6 months to less than 18 years
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- CSL Limited
- 入组人数
- 2,025
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Healthy children were eligible for enrollment if they were aged 6 months to less than 18 years and were born at or after 36 weeks gestation (this criterion applied only to participants aged younger than 9 years) or returned a negative pregnancy test (this criterion applied only to female participants aged 9 years or older).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2025
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •An allergy to any vaccine components; evidence of an active infection; receipt of an experimental or seasonal influenza vaccine in the previous 6 months; a confirmed or suspected immunosuppressive condition; a history of Guillain-Barré Syndrome; a major congenital defect or serious illness; a history of neurologic disorders or seizures; administration of immunoglobulins or any blood products; participation in a clinical study or use of an investigational compound; immunosuppressive or immunomodulatory medication, including systemic corticosteroids; and treatment with cytotoxic drugs.
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