Safety Study About the mRNA Vaccines Against COVID-19 in Pediatric Patients (PEDIVACOV-HCSC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,100
- 试验地点
- 1
- 主要终点
- Incidence of vaccine side effects
研究概览
简要总结
Drugs side effects in children need to be evaluated in a different way because of their constant growth and body changes.
The use of COVID-19 vaccines (mRNA vaccines) is worldwide spread as a safety measure against the pandemic.
Although clinical trials have shown that vaccines are safe in the general population, specific real-life monitoring is needed to address the special situation that applies to children.
详细描述
Drug-related side effects are an important health problem causing an increase in health costs. Most of the related research is focused on the adult population, therefore evidence in pediatric patients is scarse. This situation remains true in the clinical trials of the mRNA vaccines against COVID-19, with most studies suggesting the need of a greater follow up and specific research that address the pediatric population. Even though vaccines seem to be a safe and effective ways to protect the population against the COVID-19 pandemic, more information is needed regarding the safety profile for pediatrics in the short and long term.
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
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of both sexes between 5 and 12 years old.
- •Pediatric patients with data included in the Clinico San Carlos' Hospital available for consultation.
- •Acceptance by the parents/legal guardians for the participation and follow up.
排除标准
- 未提供
研究组 & 干预措施
Vaccinated children
Children between 5 and 12 years old vaccinated with 2 doses of an approved mRNA vaccione against COVID-19.
干预措施: mRNA COVID-19 vaccine (Biological)
结局指标
主要结局
Incidence of vaccine side effects
时间窗: 10 days, 1 month and 6 months after vaccination
Incidence of vaccine side effects
次要结局
- Vaccine side effects(10 days, 1 month and 6 months after vaccination)
- Time to vaccine side effect(10 days, 1 month and 6 months after vaccination)
- Causality of side effects(10 days, 1 month and 6 months after vaccination)
- Severity of side effects(10 days, 1 month and 6 months after vaccination)
- Vaccine and drug interactions(10 days, 1 month and 6 months after vaccination)
- Vaccine reactogenicity(10 days, 1 month and 6 months after vaccination)
- Perceived quality of the vaccination system(10 days, 1 month and 6 months after vaccination)
研究者
Ana Belen Rivas Paterna
designed by Principal Investigator
Hospital San Carlos, Madrid