Last reviewed · How we verify

NCT04613817: SeCoBelChild

Sero-prevalence COVID-19 Among Belgian Children

Completed Last updated 13 May 2022
What this trial tests

trial in SARS-CoV-2 in 2,103 participants. Completed in 31 December 2021.

Timeline
3 December 2020
Primary endpoint
17 December 2021
31 December 2021

Quick facts

Lead sponsorSciensano
StatusCompleted
Study typeOBSERVATIONAL
Enrollment2,103
Start date3 December 2020
Primary completion17 December 2021
Estimated completion31 December 2021
Sites1 location across Belgium

Conditions studied

Sponsor

Sciensano

Who can join

Adults 8 to 14, any sex, with SARS-CoV-2 or SARS-CoV Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. SARS-CoV-2 seroprevalence and determinants for salivary seropositivity among pupils and school staff: a prospective cohort study.
    Merckx J, Callies M, Kabouche I, Desombere I, et al · · 2023 · cited 3× · PMID 37092673 · DOI 10.1017/s0950268823000584
  2. SARS-CoV-2 infection prevention and control measures in Belgian schools between December 2020 and June 2021 and their association with seroprevalence: a cross-sectional analysis of a prospective cohort study.
    Callies M, Kabouche I, Desombere I, Merckx J, et al · · 2023 · cited 2× · PMID 37194008 · DOI 10.1186/s12889-023-15806-5
  3. Measures for infection prevention and control of SARS-CoV-2 in Belgian schools between December 2020 and June 2021: a prospective cohort study
    Callies M, Kabouche I, Desombere I, Merckx J, et al · · 2022 · cited 1× · DOI 10.1101/2022.04.12.22273722

Verify or expand the search:

Other recruiting trials for SARS-CoV-2

Currently open trials in the same condition.

Other Sciensano trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04613817.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing