EUCTR2009-016078-33-BE进行中（未招募）不适用
A phase III, observer-blind, randomised trial to evaluate the safety and immunogenicity of a two-dose schedule of the A/California/7/2009 (H1N1)v-like candidate vaccine manufactured in Dresden adjuvanted or not with AS03A in adults aged 18 to 60 years. - FLU D-PAN H1N1-AS03-033
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 128
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
- •- A male or female aged 18 to 60 years at the time of the first vaccination.
- •- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- •- Written informed consent obtained from the subject.
- •- Satisfactory baseline medical assessment by history and physical examination (stable health status with no exclusionary medical or psychiatric conditions). Stable health status is defined as the absence of health event satisfying the definition of an SAE, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrolment.
- •- Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or multiple-user device.
- •- Female subjects of non-childbearing potential may be enrolled in the study.Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- •- Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. Potential subjects in the follow-up phase of a prior investigational study may be enrolled if the investigator’s judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial.
- •Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- •Presence of an axillary temperature = 37.5°C, or acute symptoms greater than mild” severity on the scheduled date of first vaccination.
- •Diagnosed with cancer, or treatment for cancer, within the past three years.
- •-Persons with a history of cancer who are disease-free without treatment for three years or more are eligible.
- •-Persons with a history of histological-confirmed basal cell carcinoma of the skin successfully treated with local excisions only are excepted and may enrol within three years of diagnosis, but other histological types of skin cancer require a 3 year untreated and disease-free window as above.
- •-Women who are disease free three years or more after the treatment for breast cancer and receiving long-term prophylactic hormonal therapy are excepted and may enrol.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus infection.
- •Clinically or virologically confirmed influenza infection within six months preceding the study start.
- •Chronic administration of immunosuppressants or other immune modifying drugs within six months of study enrolment or planned administration during the study period. For corticosteroids, this will mean a dose equivalent to 20 mg/day of prednisone or equivalent for persons for > two weeks. Inhaled and topical steroids are allowed.
- •Receipt of any immunoglobulins and/or any blood products within three months of study enrolment or planned administration of any of these products during the study period.
- •Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
- •An acute evolving neurological disorder or history of Guillain-Barré syndrome.
- •Administration of any vaccines within 30 days before vaccination.
- •Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
- •Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
研究者
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