Seroprevalence of Infection-induced IgG Antibodies to SARS-CoV-2 in Children Seeking Medical Care in Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,032
- 试验地点
- 1
- 主要终点
- Immunoglobulins (G) to SARS-CoV-2 in plasma
研究概览
简要总结
It is unknown what proportion of children have been exposed to SARS-CoV-2 and how many have antibodies among children seeking medical care for non-Covid-19 related conditions.
The aim of this study is to identify children with IgG antibodies to SARS-CoV-2 who have not been previously diagnosed and are presumed/confirmed Covid-19 negative, then determine the level of immunity in this population which could inform further decisions about covid-19 vaccine strategies for children
详细描述
Enrolled participants will have a survey about demographic information, history of previous suspected/confirmed Covid-19 infection or exposed to SARS-CoV-2, Covid-19 vaccination status. For participants aged less than 12 months, participants' mothers' status of Covid-19 vaccination and/or previous infection will be recorded. Participants will then complete serologic testing for SARS-CoV-2 IgG antibodies using residual plasma specimens collected/stored for routine laboratory tests on the date of enrollment. The study will characterize the prevalence of antibody positivity in this population and assess whether there is a correlation between demographic characteristics and antibodies levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≤ 18 years old.
- •Seeking medical care at Vietnam National Children's Hospital for any condition not related to acute Covid-19
- •Have not been previously diagnosed and are presumed/confirmed COVID-19 negative
- •Have blood specimens collected for any routine biochemistry test on the date enrollment
排除标准
- •Refusal to participate in this study.
结局指标
主要结局
Immunoglobulins (G) to SARS-CoV-2 in plasma
时间窗: 6 month
Mean antibody titres (IgG) to SARS-CoV-2 in plasma using SIEMENS assays
The percentage of children with IgG SARS-CoV-2 antibodies in Plasma
时间窗: 6 month
The percentage of children with IgG SARS-CoV-2 antibodies to the total number of children enrolled in the study
次要结局
- Measure of association between SARS-CoV-2 IgG seropositivity and characteristics(6 month)
研究者
Phuc Huu Phan
Physician
National Children's Hospital, Vietnam