EUCTR2006-004354-24-GB进行中（未招募）1 期
A Phase IV, Randomised, Observer-Blind,Comparator-Controlled, Single-Centre Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL Influenza Vaccine (Enzira) (2006/2007) in Healthy Older Adults aged >=65 years
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- CSL Limited
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. healthy adults aged >= 65 years at the time of informed consent
- •2. provides written informed consent and adherence to all protocol requirements
- •3. is in good health, as determined by medical history and physical examination where indicated
- •4. is able to understand and comply with planned study procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Hypersensitivity to eggs, chicken protein, neomycin, polymyxin, gentamicin sulphate, formaldehyde, sodium deoxycholate, thiomersal or any components of the Study Vaccines;
- •2. Interpandemic vaccination against influenza or laboratory culture confirmed Influenza in 2006;
- •3. Vaccination with an experimental influenza vaccine (eg. a candidate pandemic influenza vaccine or a novel influenza vaccine) in 2006;
- •4. Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality;
- •5. Known history of Guillain-Barré Syndrome;
- •6. Clinical signs of active infection and/or an oral temperature of >= 38°C (100.4°F). Study entry may be deferred for such individuals, at the discretion of the Principal Investigator (PI);
- •7. Active neurological disease;
- •8. Confirmed or suspected immunosuppressive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder;
- •9. Current treatment with warfarin or other anticoagulant;
- •10. Current (or within the 90 days prior to receiving the Study Vaccines) immunosuppressive or immunomodulative therapy, including systemic corticosteroids, as follows:
- •· Chronic or long term corticosteroids: >15mg/day of oral prednisolone or equivalent daily;
- •· Sporadic corticosteroids: >40mg/day of oral prednisolone or equivalent for more than two courses of >14 days in the three months preceding vaccination;
- •· Administration of immunogobulins and/or any blood products within the 3 months preceding the administration of the Study Vaccine or during the study
- •Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccines or throughout the Study is acceptable.
- •11. Participation in a clinical trial where the participant received an investigational product or use of an investigational compound (i.e. a new chemical or biological entity not registered for clinical use) within 30 days prior to receiving the Study Vaccines or plans to enter a clinical trial during the study period;
- •12. Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving the Study Vaccines;
- •13. Current treatment, or treatment with cytotoxic drugs or radiotherapy at any time during the six months prior to administration of the Study Vaccines;
- •14. Major congenital defects or serious chronic illness;
- •15. Evidence, or history (within the previous 12 months) of drug or alcohol abuse;
- •16. Unwillingness or inability to comply with the study Protocol;
- •17. History of psychiatric disorders, which, in the opinion of the Principal Investigator (PI), would prevent participants from giving proper informed consent
研究者
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