Monitoring the Effectiveness and Safety of Covid-19 Vaccines in the University Population-National University of Colombia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,078
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
There are relevant questions that need to be answered about the effectiveness and safety of COVID-19 vaccines. The objective of this observational study is to follow up the clinical outcomes after vaccination in all the headquarters of the National University of Colombia. It is a project that is considered institutional importance and is part of the actions that the National University of Colombia has proposed to the national government to accompany the national vaccination program.
The proposed follow-up includes the sociodemographic, cultural, clinical and pharmacological characterization of the vaccinated population, including the report of adverse events occurring after the vaccination process, the behavior of the population after the administration of the vaccine, monitoring serological outcomes, identification of medication errors and therapeutic failure. Three stages are proposed in which the population affiliated to UNISALUD is gradually included, then the beneficiaries and later the student community and their families.
The scope of the attached protocol includes Stage I, which corresponds to teachers and administrative staff (active and retired) linked to UNISALUD.
详细描述
OBJECTIVE: To evaluate the clinical outcomes and adverse events associated with immunization (ESAVI) of vaccines against COVID-19 in the cohort of the university community, affiliates and beneficiaries of UNISALUD and students of the National University of Colombia.
METHODOLOGY: Descriptive longitudinal, prospective and observational study. Follow-up to a cohort without a control group. Modular multi-center stage study. The development of the research is proposed through a modular, multicenter and staged study. For the first phase, all employees of the National University of Colombia (active and retired) who agree to participate in the study will be monitored. The second phase includes monitoring the beneficiaries of UNISALUD affiliates and the third phase includes students and their families. For the calculation of the sample size in phase III, it will be carried out by applying formulas for descriptive studies.
Follow-up Time: It is estimated to be one year from the date of the first dose of the vaccine. A second phase is expected to follow up the outcomes for another additional year.
Data collection: It will begin with the presentation of the informed consent for the presentation of the study. Subsequently, a periodic follow-up will be carried out via telephone or email to identify and complete the established sociodemographic, cultural, clinical and pharmacological variables.
Serological Follow-up: The humoral immune response and its duration will be analyzed through serological tests with a blood sample to a sample of the study population. Serological follow-up will be carried out in 3 moments: prior to vaccination, after the first dose of the vaccine, and at the end of the study. The collected samples will be taken to the Laboratory of the Faculty of Medicine of the National University of Colombia for their separation. Antibody analysis will be done by chemiluminescence using the Advia Centaur COV2 platform from Siemens (3).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All UN contractors (administrative, teachers and pensioners) who belong to the different UN headquarters and agree to participate in the study
排除标准
- •Contractors not not affiliated to UNISALUD
结局指标
主要结局
Adverse events
时间窗: One year
Reports of Adverse Events Associated with COVID-19 Vaccines
COVID-19 diagnosis
时间窗: One year
People who after the vaccination process are diagnosed with COVID-19
次要结局
- Serological response(One year)