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Sero-prevalence COVID-19 Among Belgian Children

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04613817
Acronym
SeCoBelChild
Enrollment
2103
Registered
2020-11-03
Start date
2020-12-03
Completion date
2021-12-31
Last updated
2022-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, SARS-CoV-2, SARS-CoV Infection

Keywords

SARS-CoV-2, COVID-19, Children, Belgium, Pandemic 2020

Brief summary

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.

Interventions

None listed

Sponsors

KU Leuven
CollaboratorOTHER
McGill University
CollaboratorOTHER
Sciensano
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change of prevalence of antibodies against SARS-CoV-2 among Belgian children aged 8-9 yearsMonth 1, Month 4, Month 7, Month 9 and Month 11Change in percentage 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 of prevalence of antibodies against SARS-CoV-2 among Belgian children aged 13-14 yearsMonth 1, Month 4 and Month 7Change in percentage 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 8-9 yearsMonth 4, Month 7, Month 9 and Month 11Change in the percentage 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 in SARS-CoV-2 seroconversion among among Belgian children aged 13-14 yearsMonth 4 and Month 7Change in the percentage 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.

Secondary

MeasureTime frameDescription
Potential risk factors for the infectionMonth 1, Month 4, Month 7, Month 9 and Month 11Proportion (%) infected children by probable exposure (probable or confirmed COVID-19 case in family or school), risk behavior and by health characteristics (co-morbidities, presence of symptoms, use of medications).
The proportion of asymptomatic cases among new cases that develop during a period of 7 monthsMonth 1, Month 4, Month 7, Month 9 and Month 11Percentage of asymptomatic cases among new cases (positive serological test) that develop during a period of 7 months

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026