RPCEC00000385已完成2 期
Phase II randomized, double-blind, parallel-group, adaptive and multicenter study to evaluate the non-inferiority of the immune response in adults of the prophylactic anti-SARS-CoV-2 vaccine candidate FINLAY-FR-1 compared to FINLAY-FR-02 in Heterologous Two Dose and One Boost Dose Schedules with FINLAY-FR-1A. (COVID-19) - SOBERANA CENTRO
Finlay Vaccine Institute (IFV)0 个研究点目标入组 1,166 人开始时间: 2021年7月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,166
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized trial. Masking: Double Blind. Control group: Uncontrolled. Assignment: Parallel. Purpose: Prevention
入排标准
- 年龄范围
- 19 years 至 80 years（—）
- 性别
- All
入选标准
- •1) Subjects aged between 19 and 80 years.
- •2) Subjects who give their informed consent to participate in the study in writing.
- •3) Women of childbearing age who use contraceptive methods during the study and are willing to use them up to three months after the corresponding vaccination schedule has concluded.
排除标准
- •1) Subjects with acute febrile or infectious disease in the seven days prior to the administration of the vaccine or at the time of its application.
- •2) Subjects with diminished mental faculties for decision making.
- •3) Subjects with a history of known hypersensitivity to any of the components of the formulation.
- •4) Previous history of SARS-CoV-2 infection or subjects positive to the antigen test at the time of inclusion.
- •5) Subjects previously vaccinated against SARS-CoV-2.
- •6) Application of vaccines containing tetanus toxoid or the VA-MENGOC-BC vaccine in the last three months.
- •7) Application of any other vaccine of the extended immunization schedule in the last 30 days.
- •8) Treatment with immunomodulators in the last 30 days, considering steroids (except topical and inhaled), cytostatics, interferon, HeberFERON, immunoferon, transfer factor, biomodulin T, any gamma globulin, levamisole, thymosin or other drugs with immunomodulatory action. In addition, those people who, due to their underlying disease, require immunomodulatory treatment during the development of the study.
- •9) Subjects with tattoos in the deltoid region on both arms.
- •10) Decompensated chronic diseases that limit vaccination according to criteria clinical.
- •11) Subjects with unstabilized malignant disease or who are receiving oncospecific treatment (cytostatics and / or radiotherapy) during the time of the study or have been receiving it in the last three months.
- •12) HIV positive subjects with detectable viral load, history of opportunistic infection or CD4 less than 200 copies.
- •13) Pregnancy, puerperium or lactation.
研究者
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