RPCEC00000374已完成1 期
Phase I-II study, sequential during phase I, open-label, adaptive and multicenter to evaluate the safety, reactogenicity and immunogenicity, of a heterologous two-dose schedule of the prophylactic anti-SARS vaccine candidate - CoV-2, FINLAY-FR- 2 and a dose of FINLAY-FR-1A, in Cuban children and adolescents. (COVID-19) - SOBERANA PEDIATRIA
Finlay Vaccine Institute (IFV)0 个研究点目标入组 350 人开始时间: 2021年6月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 350
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 3-11 years old: Informed consent of parents or legal guardians
- •- Subjects aged 12-18 years: Informed Consent of the parents or legal guardians and Informed Assent of the adolescent.
- •3. Weight-height nutritional assessment between the 10th and 90th percentile (for subjects between 3 and 9 years of age) or the Body Mass Index between the 10th and 90th percentile for subjects between 10 and 18 years of age), according to the cut-off points for the Cuban pediatric population.
- •4. General, regional and apparatus physical examination without alterations.
- •5. Laboratory results within or outside the range of reference values ??but not clinically significant (For the subjects to be included in phase I).
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 that meet any of the following criteria:
- •a) Previous or current history of SARS-CoV 2 infection.
- •b) SARS-CoV 2 PCR positive.
- •c) Be declared in the category of contact or suspect at the time of inclusion.
- •3. Subjects with a history of hypersensitivity to Thiomersal or any of the components of the formulations.
- •4. Subjects with a history of having been immunized with a SARS-CoV 2 vaccine.
- •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 product under investigation.
- •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. History of chronic diseases.
- •9. Subjects with a history of major congenital malformations (defects that have a significant functional compromise for the individual's life, have medical consequences and require early, sometimes urgent, care).
- •10. Primary or secondary immune system disease.
- •11. History of neoplastic disease.
- •12. History of severe allergic reactions.
- •13. 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).
- •14. Subjects with a history of Convulsive Disease.
- •15. History of treatment with blood products such as blood cell, plasma, whole blood or platelet concentrate transfusions in the last 4 months.
- •16. Splenectomy or splenic dysfunction.
- •17. Child with a minor or mentally disabled mother or father.
- •18. Pregnancy or lactation (a pregnancy test will be carried out before inclusion and administration of each dose to all girls and adolescents who menstruate).
- •19. Subjects with tattoos in the deltoid region of both arms.
- •20. Subjects with a history or positive results for: antibodies against HIV1 + 2, antibodies against hepatitis C, surface antigen of the hepatitis B virus or VDRL serology.
- •21. History of psychoactive substance use in the last 6 months.
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