PACTR201507001154522尚未招募Unknown
202090 (EBOLA Z CHAD3-004)
GlaxosSmithKline (GSK)0 个研究点目标入组 600 人开始时间: 2015年6月1日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
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
- 1 Year(s) 至 17 Year(s)（—）
- 性别
- All
入选标准
- •Subjects parent(s)/ legally acceptable representative(s) (LAR[s]) who, in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g., availability for Diary Card completion, return for follow-up visits, availability for clinical follow-up throughout the study period).
- •¿Written/ thumb printed informed consent obtained from the subject¿ parent(s)/ LAR(s) prior to performing any study specific procedure. In addition, written/ thumb printed informed assent should be obtained if appropriate (from all subjects aged 13 to 17 years and from younger subjects as per local requirements).
- •¿A male or female child aged 1 to 17 years inclusive at the time of Screening.
- •(Amended 06 May 2015.)
- •¿Subjects with a negative RDT test for Malaria within 30 days prior to randomisation into the study.
- •Subjects with a positive RDT test for Malaria who completed antimalarial treatment at least 5 days prior to randomisation into the study.
- •(Amended 06 May 2015.)
- •¿Healthy subjects as per Investigator judgement, as established by medical history, clinical examination and haematology/ biochemistry laboratory parameters screening before entering into the study.
- •¿Female subjects of non-childbearing potential may be enrolled in the study.
- •Non-childbearing potential is defined as pre-menarche or ovariectomy.
- •Please refer to the glossary of terms for the definition of menarche.
- •¿Female subjects of childbearing potential may be enrolled in the study, if the subject:
- •has practiced adequate contraception for 30 days prior to the Day 0 visit, and
- •has a negative pregnancy test at the Day 0 visit, and has agreed to continue adequate contraception until 30 days after the Month 6 visit. Please refer to the glossary of terms for the definition of adequate contraception
排除标准
- •Child in care.
- •Please refer to the glossary of terms for the definition of child in care.
- •(Amended 06 May 2015.)
- •¿Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the Day 0 visit, or planned use during the study period.
- •¿Previous vaccination with an investigational EBOV or Marburg vaccine, or previous vaccination with a chimpanzee adenoviral vectored investigational vaccine.
- •¿Known prior EBOV or SUDV disease.
- •¿Travel to country affected by the EBOV epidemic or direct contact with person with EVD within 21 days prior to the Day 0 visit.
- •¿History of any reaction or hypersensitivity (such as anaphylaxis, urticaria [hives], respiratory difficulty, angioedema, or abdominal pain) likely to be exacerbated by any component of the study vaccine.
- •¿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 vaccination visit.
- •¿Acute or chronic illness determined by medical history, clinical examination and laboratory screening tests including, but not limited to:
- •Clinically significant immunosuppressive or immunodeficient condition (e.g., clinical acquired immune deficiency syndrome [AIDS]).
- •Major congenital defects.
- •Malnutrition (defined as weight for age Z-score less than -3, or other clinical signs of malnutrition).
- •Any clinically significant haematological or biochemical laboratory abnormality (see APPENDIX C for acceptable limits for eligibility determination).
- •¿Pregnant female.
- •¿Any condition that in the Investigator¿s opinion may potentially compromise subject safety or interfere with subject assessment or compliance.
- •(Amended 06 May 2015.)
研究者
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