EUCTR2005-004459-36-DE进行中（未招募）不适用
A phase IV, randomized, open-label, multi-center study in adults: Evaluation of long-term immunogenicity in subjects boosted with a new TBE vaccine for adults (free of protein-derived stabilizer) in study V48P2E1, 5 years after first booster immunization and Evaluation of booster kinetics in subjects boosted with a new TBE vaccine for adults (free of protein-derived stabilizer), 5 years after first booster immunization. - not available
Chiron Behring GmbH & Co KG0 个研究点目标入组 190 人开始时间: 2005年11月7日最近更新:
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
- 入组人数
- 190
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
- •·Healthy volunteers of both sexes aged >18 who participated in study V48P2E2 and are willing to give informed consent will be included.
- •·Subjects who are available for the duration of the trial (approximately 3 weeks)
- •·Subjects who are in good health as determined by medical history, physical examination, and clinical judgment of the investigator
- •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
- •·Subjects not willing to sign the informed consent form
- •·Subjects with documented evidence of TBE
- •·Subjects who receive another vaccine within the 4 weeks before the administration of investigational product and 3 weeks after
- •·Subjects with acute disease at the day of enrollment (acute disease means moderate or severe illness with or without fever; vaccine can be administered to subjects with minor illness such as mild diarrhea or mild upper respiratory tract infection with body temperature < 38.0°C)
- •·Subjects with organic brain disturbances, including seizure disorders
- •·Subjects with progressive neurological disorders
- •·Subjects who have suffered febrile or afebrile convulsions
- •·Subjects in whom a general decrease in resistance might be expected, e.g. those who have recently sustained severe injury or undergone recent surgical operations or in whom surgical operations are planned during the study period, are undernourished, or have disorders involving a decreased immune response
- •·Subjects being treated with immunosuppressants, systemic corticosteroids for longer than 2 months within the past 4 weeks or during the study period, except for topical or inhaled therapy of mild bronchial asthma
- •·Subjects being treated with immunoglobulins, whole blood or plasma derivates within the last 3 months and during study participation
- •·Subjects with autoimmune diseases
- •·Subjects with evidence of hypersensitivity to the investigational product or chemically related substances in their medical history
- •·Subjects enrolled in other investigational studies at the same time and within the last 3 months
- •·Subjects with major congenital defects or serious chronic illness (such as insulin dependent diabetes, cancer, autoimmune diseases) as well as any active severe allergic disease
- •·Subject with any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives
- •·Woman of childbearing age who refuses to use an effective method of birth control (abstinence, oral or injected or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent, intrauterine device) beginning 30 days before study entry and continuing through 30 days after the last vaccine dose
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