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NCT05358626 Clinical Trial

Seroprevalence of Infection-induced SARS-CoV-2 Antibodies (COVID-19) in Children

COVID-19 Clinical Trial

Official title:
Seroprevalence of Infection-induced IgG Antibodies to SARS-CoV-2 in Children Seeking Medical Care in Vietnam

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05358626
Other study ID # ChildrensHVietnam
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 13, 2022
Est. completion date November 13, 2022

Study information
Verified date March 2023
Source National Children's Hospital, Vietnam
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 4032
Est. completion date November 13, 2022
Est. primary completion date June 5, 2022
Accepts healthy volunteers No
Gender All
Age group 0 Years to 18 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Refusal to participate in this study.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• SARS-CoV-2 IgG Antibody testing
IgG Antibody testing for previous exposure to SARS-CoV-2

Locations
Country Name City State
Vietnam Vietnam National Children's Hospital Hanoi

Sponsors (1)
Lead Sponsor Collaborator
National Children's Hospital, Vietnam

Country where clinical trial is conducted

Vietnam, 

Outcome
Type Measure Description Time frame Safety issue
Primary The percentage of children with IgG SARS-CoV-2 antibodies in Plasma The percentage of children with IgG SARS-CoV-2 antibodies to the total number of children enrolled in the study 6 month
Primary Immunoglobulins (G) to SARS-CoV-2 in plasma Mean antibody titres (IgG) to SARS-CoV-2 in plasma using SIEMENS assays 6 month
Secondary Measure of association between SARS-CoV-2 IgG seropositivity and characteristics socio-demographics, previous exposure to SARS-CoV-2 6 month
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