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

March 8, 2023 updated by: Phuc Huu Phan, National Children's Hospital, Vietnam

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

4032

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam
        • Vietnam National Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

In-patient or out-patient children aged from 0 to 18 years old, who have not have not been previously diagnosed and are presumed/confirmed COVID-19 negative, have blood specimens collected for routine biochemistry tests.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of children with IgG SARS-CoV-2 antibodies in Plasma
Time Frame: 6 month
The percentage of children with IgG SARS-CoV-2 antibodies to the total number of children enrolled in the study
6 month
Immunoglobulins (G) to SARS-CoV-2 in plasma
Time Frame: 6 month
Mean antibody titres (IgG) to SARS-CoV-2 in plasma using SIEMENS assays
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of association between SARS-CoV-2 IgG seropositivity and characteristics
Time Frame: 6 month
socio-demographics, previous exposure to SARS-CoV-2
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Children's Hospital, Vietnam

Investigators

  • Principal Investigator: Phuc H Phan, MD, Vietnam National Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2022

Primary Completion (Actual)

June 5, 2022

Study Completion (Actual)

November 13, 2022

Study Registration Dates

First Submitted

April 30, 2022

First Submitted That Met QC Criteria

April 30, 2022

First Posted (Actual)

May 3, 2022

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChildrensHVietnam

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on SARS-CoV-2 IgG Antibody testing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe