EUCTR2014-004714-28-Outside-EU/EEA进行中（未招募）不适用
A Phase 2, randomised, observer-blind, controlled, multi country study to assess the safety and immunogenicity of a single intramuscular dose of GSK Biologicals’ investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A), in children 1 to 17 years of age in Africa - EBOLA Z CHAD3-004
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subject’s 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, availa-bility 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.
- •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.
- •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 premenarche or ovariectomy.
- •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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 600
- •F.1.2 Adults (18-64 years) no
- •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
- •Child in care.
- •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.
- •Pregnant female.
- •Any condition that in the Investigator’s opinion may potentially compromise subject safety or interfere with subject assessment or compliance.
研究者
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