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

NCT ID: NCT05358626

Last Updated: 2023-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4032 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-13

Study Completion Date

2022-11-13

Brief Summary

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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

Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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SARS-CoV-2 IgG Antibody testing

IgG Antibody testing for previous exposure to SARS-CoV-2

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Children's Hospital, Vietnam

OTHER

Sponsor Role lead

Responsible Party

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Phuc Huu Phan

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Phuc H Phan, MD

Role: PRINCIPAL_INVESTIGATOR

Vietnam National Children's Hospital

Locations

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Vietnam National Children's Hospital

Hanoi, , Vietnam

Site Status

Countries

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Vietnam

Other Identifiers

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ChildrensHVietnam

Identifier Type: -

Identifier Source: org_study_id

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