RPCEC00000424尚未招募Unknown
Post - authorization study to evaluate the immunogenicity and safety of SOBERANA® 02 and SOBERANA® Plus as a booster of immunity against the omicron variant of sars-cov-2, in adult subjects.
Finlay Institute of Vaccines (IFV)0 个研究点目标入组 306 人开始时间: 2023年5月19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
- 306
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: Open. Control group: Uncontrolled. Assignment: Parallel. Purpose: Prevention
入排标准
- 年龄范围
- 19 years 至 one（—）
- 性别
- All
入选标准
- •1. Subjects of both sexes, over 18 years of age.
- •2. Subjects who give their informed consent to participate in the study.
- •3. Subjects who received the primary vaccination schedule against SARS-CoV-2 or convalescent subjects from COVID-19 in a period greater than or equal to 6 months.
排除标准
- •1. Subjects with febrile or acute infectious disease in the 7 days prior to the administration of the vaccine or at the time of its application.
- •2. Subjects with chronic diseases NOT controlled, according to clinical criteria.
- •3. Subjects with a history of severe allergy (anaphylactic shock, angioneurotic edema, edema of the glottis, severe urticaria) to SOBERANA® 02 and SOBERANA® Plus vaccines.
- •4. Subjects convalescent from COVID-19 in a period of less than 6 months.
- •5. Having received a booster dose against SARS-CoV-2 in less than 6 months.
- •6. Application of another vaccine in the last 30 days.
- •7. Previous vaccination with tetanus toxoid vaccine in a period of less than 6 months.
- •8. History of having received a transfusion of blood or blood products in the last 3 months.
- •9. Women of childbearing age with a history of amenorrhea greater than 4 weeks or pregnant.
研究者
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