EUCTR2008-005324-93-GB进行中（未招募）不适用
A Single Centre, Open-Label Study to Evaluate the Immunogenicity and Safety of Enzira® vaccine in Healthy ‘Adults’ aged = 18 to < 60 years and in Healthy ‘Older Adults’ aged = 60 years for the 2008/2009 Northern Hemisphere Influenza Season
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
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 males or females, aged = 18 years at the time of providing informed consent.
- •2. Provision of written informed consent to participate in the study and willingness to adhere to all Protocol requirements.
- •3. Be able to provide a sample of up to 17 ml of venous blood on two separate occasions without undue distress/discomfort.
- •4. Negative pregnancy test at enrolment before receiving Study Vaccine (female participants of child-bearing potential ONLY). Those at risk of pregnancy during the study period must, in the opinion of the Investigator, be taking/using adequate methods of contraception. Adequate methods are defined as:
- •Oral contraception
- •Intrauterine contraceptive device
- •Depot contraceptive (implants/injectables)
- •Abstinence
- •Partner Vasectomy
- •Condoms with spermicide.
- •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, or any components of the vaccine.
- •2. Vaccination against influenza within the previous 6 months.
- •3. Clinical signs of active infection and/or an oral temperature of = 38oC at study entry. Study entry may be deferred for such individuals, at the discretion of the PI/delegate.
- •4. Confirmed or suspected immunosuppressive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder.
- •5. Current (or within the 90 days prior to receiving the Study Vaccine) immunosuppressive or immunomodulative therapy, including systemic corticosteroids, as follows:
- •Chronic or long-term corticosteroids: = 15 mg/day of oral prednisolone or equivalent daily.
- •Sporadic corticosteroids: = 40 mg/day of oral prednisolone or equivalent for two or more short courses of > 3 days in the three months preceding vaccination.
- •Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccine or throughout the Study is acceptable.
- •6. Participation in a clinical trial or use of an investigational compound (i.e. a new chemical or biological entity not registered for clinical use) within 90 days prior to receiving the Study Vaccine or plans to enter a study during the study period.
- •7. Vaccination with any registered vaccine within 30 days prior to receiving the Study Vaccine.
- •8. Current treatment, or treatment with cytotoxic drugs at any time during the six months prior to administration of the Study Vaccine.
- •9. Known history of Guillain-Barré Syndrome.
- •10. Active neurological disease.
- •11. Current treatment with warfarin or other anticoagulant;
- •12. Physical/Medical history that the Investigator feels may adversely affect the participant or study results.
- •13. Evidence, or history (within the previous 12 months) of drug or alcohol abuse.
- •14. Unwillingness or inability to comply with the study Protocol.
- •15. History of psychiatric disorders, which, in the opinion of the Principal Investigator, would prevent the participant from giving proper informed consent.
研究者
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