RPCEC00000384招募中2 期
Exploratory and open study, to evaluate the safety, reactogenicity and immunogenicity, of a heterologous scheme of two doses of the prophylactic anti SARS vaccine candidate - CoV - 2, FINLAY-FR-2 and one dose of FINLAY-FR-1A, in Cuban children and adolescents (COVID-19) - SOBERANA PEDIATRIA CLINICA 1
Instituto Finlay de Vacunas (IFV)0 个研究点目标入组 425 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
- 招募中
- 发起方
- 入组人数
- 425
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
- N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Prevention
入排标准
- 年龄范围
- 3 years 至 18 years（—）
- 性别
- All
入选标准
- •1) Subjects aged between 3 and 18 years.
- •2) Voluntariness expressed through informed consent to participate in the study: - Subjects aged 3-11 years: Informed consent of the father, mother or legal guardian. - Subjects aged 12-18 years: Informed Consent of the father, mother or legal guardian and Informed Assent of the adolescent.
- •3) General, regional and apparatus physical examination without alterations.
排除标准
- •1) Subjects with acute febrile or infectious disease at the time of the vaccine application or in the 7 days prior to its administration.
- •2) Subjects meeting any of the following criteria:
- •a) Previous or current history of SARS-CoV 2 infection.
- •b) Being declared in the contact or suspect category at the time of inclusion.
- •3) Subjects with a history of hypersensitivity to Thimerosal or any of the components of the formulations.
- •4) Subjects with a history of having been immunized with a vaccine against SARS-CoV 2.
- •5) Subjects with a history of having received a vaccine from the Cuban immunization scheme, in a period of less than 30 days prior to the administration of the investigational product .
- •6) Use of any investigational product in the 30 days prior to immunization.
- •7) Application of vaccines containing tetanus toxoid in the last 3 months.
- •8) Subjects with a history of major congenital malformations (defects that have an important functional compromise for the individual's life, have medical consequences and require early attention, sometimes urgently).
- •9) Primary or secondary immune system disease.
- •10) History of neoplastic disease.
- •11) History of severe allergic reactions.
- •12) Treatment with immunomodulators in the last 30 days (eg steroids (except topical and inhaled), Interferon, Immunoferon, Nasalferon, Transfer Factor, monoclonal antibody, Biomodulin T, any ganmaglobulin, Heberferon, Thymosin, Levamisole).
- •13) Subjects with a history of Convulsive Disease.
- •14) History of treatment with blood products such as blood cell, plasma, whole blood or platelet concentrate transfusions in the last 4 months.
- •15) Splenectomy or splenic dysfunction.
- •16) Pregnancy or lactation (a pregnancy test will be carried out before inclusion and administration of each dose to all girls and adolescents who menstruate).
- •17) Subjects with tattoos in the deltoid region of both arms.
- •18) Subjects with a history of HIV1 + 2 antibodies, hepatitis C antibodies, hepatitis B virus surface antigen, or VDRL serology.
- •19) History of psychoactive substance use in the last 6 months.
研究者
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