PACTR201504001092179尚未招募未知
202091 (EBOLA Z CHAD3-005)
GlaxosSmithKline (GSK)0 个研究点目标入组 3,000 人开始时间: 2015年4月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,000
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 999 Year(s)（—）
- 性别
- All
入选标准
- •All subjects must satisfy ALL the following criteria at study entry:
- •¿ Subjects who, in the opinion of the Investigator, can and will comply with the
- •requirements of the protocol (e.g. capability of or 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 prior to
- •performing any study specific procedure or written/ thumb printed informed
- •consent obtained from the subject¿s parent(s)/ legally acceptable representative(s)
- •(LAR[s]) and written/ thumb printed informed assent obtained from the subject,
- •for minor subjects. This will only be applicable for countries where the legal age of
- •majority is ¿ 21 years.
- •(Amended 17 February 2015.)
- •¿ A male or female aged 18 years of age or older at the time of Screening.
- •(Amended 17 February 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, current tubal ligation,
- •hysterectomy, ovariectomy or post-menopause.
- •Please refer to the glossary of terms for the definition of menarche and menopause.
- •¿ 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
排除标准
- •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 a country affected by the EBOV epidemic or direct contact with a 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.
- •¿ Serious acute or chronic illness determined by medical history and clinical
- •examination including, but not limited to:
- •¿ Clinically significant immunosuppressive or immunodeficient condition (e.g.
- •clinical acquired immune deficiency syndrome [AIDS]).
- •¿ Any clinically significant haematological (CBC, including differential count and
- •platelet count) or biochemical (ALT, creatinine) laboratory abnormality. Refer to
- •APPENDIX C for acceptable limits for eligibility determination.
- •¿ Any chronic illness with recent signs of exacerbation, or imposing a change in
- •the chronic treatment regimen, within 3 months prior to the Day 0 visit.
- •¿ Any unstable chronic medical condition (e.g. uncontrolled asthma).
- •¿ Pregnant female.
研究者
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