RPCEC00000340
已完成
1 期
Phase I study, open, sequential and adaptive for evaluating the safety, reactogenicity and explore the immunogenicity of the prophylactic Vaccine Candidate FINLAY-FR-2 anti SARS-CoV-2 (COVID-19) - SOBERANA 02
Finlay Vaccine Institute (IFV)0 个研究点目标入组 40 人2020年10月27日
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Prevention of COVID-19
- 发起方
- Finlay Vaccine Institute (IFV)
- 入组人数
- 40
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Subjects who give their informed consent to participate in the study in writing.
- •2\. Subjects aged between 19 and 59 years.
- •3\. Women of childbearing potential use safe contraceptive methods during the study.
- •4\. General, regional and apparatus physical examination: normal or without clinically significant alterations.
- •5\. Laboratory results within or outside the range of reference values ??but not clinically significant.
排除标准
- •1\. Subjects with acute febrile or infectious disease in the 7 days prior to the administration of the vaccine or at the time of its application.
- •2\. Subjects with antimicrobial treatment in the 7 days prior to the administration of the vaccine.
- •3\. Subjects with Weight Loss (BMI \<18\.5\) and Obesity (BMI \= 30\.0\)
- •4\. Subjects with chronic non\-communicable diseases not controlled according to clinical or laboratory criteria (eg bronchial asthma, chronic obstructive pulmonary disease, diabetes mellitus, thyroid diseases, ischemic heart disease, arterial hypertension, psychiatric, neurological, hemolymphopoietic system disease ).
- •5\. Subjects with congenital or acquired immune system disease.
- •6\. Subjects with a history of unresolved neoplastic disease.
- •7\. Subjects with a personal history of liver or kidney failure.
- •8\. Subjects with a history of substance abuse within the past 30 days or substance addictive illness, except withdrawal and smoking.
- •9\. Subjects with diminished mental faculties for decision making.
- •10\. Subjects with a history of severe allergic disease (anaphylactic shock, angioneurotic edema, glottis edema, severe urticaria).
结局指标
主要结局
未指定
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进行中（未招募）
不适用
A phase I/II, open, controlled study in order to evaluate the reactogenicity and the immunogenicity of GlaxoSmithKline Biologicals influenza candidate vaccine containing the adjuvant AS25 (FluAS25) in an elderly population aged over 65 years (>65 years-old) previously vaccinated in 2004 with the same candidate vaccine in FLUAS25-001 clinical trial. For immunogenicity and safety evaluations, Fluarix™ (known as alpha-Rix™ in Belgium)vaccine will be used as reference. - FLUAS25-002EUCTR2005-001928-37-BEGlaxoSmithKline Biologicals100