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临床试验/NCT04613817
NCT04613817已完成不适用

Prevalence and Incidence of Antibodies Against SARS-CoV-2 in Children Measured for One Year in Belgium: a Sero-epidemiological Prospective Cohort Study

Sciensano1 个研究点 分布在 1 个国家目标入组 2,103 人开始时间: 2020年12月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Sciensano
入组人数
2,103
试验地点
1
主要终点
Change of prevalence of antibodies against SARS-CoV-2 among Belgian children aged 8-9 years

研究概览

简要总结

Based on studies in China, Iceland, the Netherlands and Italy it seems that children are less affected by SARS-CoV-2 infections and play a lesser role in the dissemination of the SARS-CoV-2 virus. It is unclear to which extend this is due to lesser exposure or an inherent decreased susceptibility to become infected. The low reported number of cases in children can be partially explained by the lower testing rates in the pediatric population.

To get insight in the transmission of SARS-CoV-2 virus in school-aged children it is necessary to compile data on infection of SARS-CoV-2 virus in the child and (pre-)adolescent population. The main objective of this study is to determine the sero-prevalence and sero-conversion of antibodies against SARS-CoV-2 in a sample of school-aged children (primary and secondary school) in Belgium at different time points. Additionally this study will gain insight in the incidence of SARS-CoV-2, the proportion of asymptomatic infections with SARS-CoV-2 and the role of COVID-19 infection in household members. It will give us the possibility to investigate potential risk factors for infection.

The study population includes primary and secondary school children from two predefined age groups (8-9 and 13-14 years old). These two groups are chosen because studies have shown more pronounced symptoms of infection and disease depending on age and because transmission dynamics also vary by age. The study population will be recruited in all Belgian schools including Brussels-Capital, Flemish and Walloon Region (including the German speaking community).

The study is a prospective cohort study. In total there will be 3 testing points with 3 months between each point. The sample size calculation indicated the inclusion of 41 randomly selected primary and 41 secondary schools and in each school 20 randomly selected pupils of the defined age groups. Parents/legal child caregiver will complete a questionnaire at each of the testing points providing basic socio-demographic characteristics (at baseline only) and risk-behavior and health characteristics including presence of symptoms during the time since the previous testing point (at each of the testing points). The questionnaire will be completed through a secured online application during the same week as the child had the saliva sample for serological testing taken.

Saliva samples will be sent to the Sciensano laboratory for serological analysis. The child's parent/legal caregiver will be informed of the serological result.

Study data will guide the Belgian policy makers in their advices to limit circulation of SARS-CoV-2 in Belgium and more specifically in their advice on measures for school-age children. This data might also be used to guide health authorities that have to decide on vaccination strategies once a vaccine is available; to decide whether children should be included for vaccination to create herd immunity or not.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
8 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Primary schools: any pupil from the 3rd grade (or from the 2nd grade if not enough participants from 3rd grade are available in the selected school) who regularly attend school and is present at school at the first testing point
  • Secondary schools: any pupil from 2nd grade who regularly attend school and is present at school at the first testing point
  • Prior known SARS-CoV-2 infection does not exclude participation

排除标准

  • Pupils who refuse to have the saliva sample taken
  • Being a sibling of a study participant
  • No informed consent form signed by parent of legal caregiver available at the recruitment

结局指标

主要结局

Change of prevalence of antibodies against SARS-CoV-2 among Belgian children aged 8-9 years

时间窗: "Month 1", "Month 4", "Month 7", "Month 9" and "Month 11"

Change in the absolute numbers of children aged 8-9 years with specific SARS-CoV-2 IgG/IgM detected in their saliva by ELISA (positive SARS-CoV-2 serological test) among all children tested

Change in SARS-CoV-2 seroconversion among among Belgian children aged 8-9 years

时间窗: "Month 4", "Month 7", "Month 9" and "Month 11"

Change in the absolute number of children aged 8-9 years with specific SARS-CoV-2 IgG/IgM detected in their saliva by ELISA (positive SARS-CoV-2 serological test) among all children tested at each of the study follow-up testing points that did not have a positive SARS-CoV-2 serological test before.

Change of prevalence of antibodies against SARS-CoV-2 among Belgian children aged 13-14 years

时间窗: "Month 1", "Month 4" and "Month 7"

Change in the absolute numbers of children aged 13-14 years with specific SARS-CoV-2 IgG/IgM detected in their saliva by ELISA (positive SARS-CoV-2 serological test) among all children tested

Change in SARS-CoV-2 seroconversion among among Belgian children aged 13-14 years

时间窗: "Month 4" and "Month 7"

Change in the absolute number of children aged 13-14 years with specific SARS-CoV-2 IgG/IgM detected in their saliva by ELISA (positive SARS-CoV-2 serological test) among all children tested at each of the study follow-up testing points that did not have a positive SARS-CoV-2 serological test before.

次要结局

  • The proportion of asymptomatic cases among new cases that develop during a period of 7 months("Month 1", "Month 4", "Month 7", "Month 9" and "Month 11")
  • Potential risk factors for the infection("Month 1", "Month 4", "Month 7", "Month 9" and "Month 11")

研究者

发起方
Sciensano
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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