EUCTR2009-011450-18-GB进行中（未招募）不适用
A Phase IV, Single-centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2009/2010 Formulation of the Enzira® Vaccine in Two Groups of Healthy Volunteers: ‘Adults’ (aged = 18 to < 60 years) and ‘Older Adults’ (aged = 60 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
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. Males or females aged = 18 years at the time of providing informed consent.
- •2. Participants are capable of understanding the purposes and risks of the study and are able to provide written informed consent.
- •3. Willing and able to adhere to all protocol requirements
- •4. Able to provide a sample of up to 17 ml of venous blood on two separate occasions without undue distress/discomfort.
- •5. Females of child bearing potential (i.e. ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Accepted contraceptive precautions are determined as: oral contraception, intrauterine contraceptive device or equivalent hormonal contraception (e.g. progestogen-only implant, vaginal contraceptive ring, cutaneous hormonal patch or injectable contraceptives), abstinence, partner vasectomy, condoms used in conjunction with spermicide. Females of child bearing potential must return a negative urine pregnancy test result at enrolment, prior to vaccination with Enzira® vaccine.
- •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. Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Enzira® vaccine.
- •2. Clinical signs of an active infection and/or an elevated oral temperature (= 38.0°C) at study entry.
- •3. A clinically significant medical or psychiatric condition, as follows:
- •For acute conditions (active or recent); the condition required hospitalisation within the last month; or
- •For chronic conditions: the Investigator feels that the chronic condition is unstable, such as illness exacerbations within the previous month:
- •i. requiring hospitalisation;
- •ii. with significant organ function deterioration;
- •iii. with major changes to treatment dosages;
- •iv. requiring major new treatments; or
- •The Investigator feels the participant has a clinical condition that may be adversely affected through study participation.
- •4. A confirmed or suspected immunosuppressive condition (congenital or acquired; including cancer and human immunodeficiency virus infection).
- •5. History of seizures, with the exception of a past history of a single seizure event at any age that occured more than 2 years previously;
- •6. History of Guillain-Barré Syndrome.
- •7. Vaccination with a seasonal influenza virus vaccine or with an experimental influenza virus vaccine (e.g. a candidate pandemic influenza virus vaccine or a novel influenza virus vaccine) in the 6 months preceding study entry.
- •8. Currently receiving treatment with radiotherapy or cytotoxic drugs, or have received such treatment within the 6 months preceding administration of the Enzira® vaccine.
- •9. Currently receiving systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry:
- •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 2 or more short courses of > 3 days in the 3 months preceding vaccination;
- •10. Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of the Enzira® vaccine.
- •11. Currently participating in another investigational study or recent study participation ending 3 months preceding administration of the Enzira® vaccine.
- •12. Currently receiving treatment with warfarin or other anticoagulants.
- •13. Evidence or history of substance or alcohol abuse within the 12 months before study entry.
- •14. Females of child bearing potential who are planning to become pregnant or planning to discontinue contraceptive precautions during the study period.
- •15. Females who are pregnant or lactating.
- •16. Any issues that, in the opinion of the investigator, would render the subject unsuitable for study participation.
研究者
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