An Open-Label, Multi-Centre Study to Evaluate the Safety, Tolerability and Immunogenicity of CSL's Influenza Vaccine in a Paediatric Population (= or >6 Months to < 9 Years of Age).

CSL Limited0 个研究点目标入组 300 人开始时间: 2016年8月5日最近更新: 2016年8月16日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: CSL Limited
入组人数: 300

研究概览入排标准研究者记录与标识符相似试验

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

•1. Be healthy male or female children, aged = or > 6 months to < 9 years at the time of first study vaccination; Note: = or > 6 refers to 6 calendar months 2. Parent(s) or Guardian(s) to provide written informed consent to participate in the study;
•3. Be able to provide a pre-vaccination sample of up to 5mL of venous blood without undue distress/discomfort and,
•4. Be born after a normal gestation period (between 36 and 42 weeks).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 300
•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

•1. Known allergy to eggs, chicken feathers, neomycin, polymyxin, or any components of the vaccine;
•2. Previous influenza vaccination;
•3. Clinical signs of active infection and/or an axillary temperature of = or >37.5 degrees Celsius or oral temperature of = or >38 degrees Celsius at study entry. Study entry may be deferred for such individuals, at the discretion of the Principal Investigator;
•4. Confirmed or suspected immunosuppressive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder (including HIV);
•5. Current (or within the 90 days prior to receiving the Study Vaccine) treatment with immunosuppressive or immunomodulative medication, including systemic corticosteroids, as follows: •Chronic or long term corticosteroids: >0.5mg/kg/day of oral prednisolone or equivalent (Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccine or throughout the Study is acceptable).
•6. Administration of immunoglobulins and/or any blood products since birth or planned administration of such blood products during the study period;
•7. Participation in a clinical study or use of an investigational compound (ie a new chemical or biological entity not registered for clinical use), within the 90 days prior to receiving the Study Vaccine or be planning to enter such a study during the study period;
•8. Current treatment with cytotoxic drugs or treatment within the 6 months prior to administration of the Study Vaccine;
•9. Have a known history of Guillain-Barré Syndrome;
•10. Have a major congenital defect or serious illness and
•11. Have a history of neurologic disorders or seizures.

研究者

发起方

CSL Limited

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