PACTR201311000639144招募中未知
Efficacy of GSK Biologicals candidate tuberculosis (TB) vaccine GSK 692342 against TB disease, in adults living in a TB endemic region
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 3,506
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Year(s) 至 50 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •-A male or female between, and including, 18 and 50 years of age at the time of obtaining informed consent.
- •-Written (or thumb printed and witnessed) informed consent obtained from the subject.
- •-Baseline positive IGRA test result.
- •-Baseline negative HIV screen.
- •-Baseline negative clinical screening questionnaire and negative sputum sample for Pulmonary TB disease.
- •-Healthy subjects or those with chronic well-controlled disease as established by medical history and clinical examination.
- •-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 25 days prior to vaccination, and has a negative pregnancy test on the day of screening and the day of first vaccination, and has agreed to continue adequate contraception during the entire vaccination period and for 2 months after completion of the vaccination series.
排除标准
- •-Current TB disease or history of TB disease and/or treatment for TB.
- •-Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •-Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after each dose of vaccine.
- •-History of previous administration of experimental Mtb vaccines.
- •-Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.Inhaled and topical steroids are allowed.
- •-Any condition or illness or medication, which in the opinion of the Investigator might interfere with the evaluation of the safety or immunogenicity of the vaccine.
- •-Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •-Planned participation or participation in another experimental protocol during the study.
- •-Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- •-Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- •-History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •-History of medically confirmed autoimmune disease.
- •-Pregnant or lactating female.
- •-Female planning to become pregnant or planning to discontinue contraceptive precautions during the vaccination period and/or before 2 months after completion of the vaccination series.
研究者
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