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SARS-CoV-2SeCoBelChildNCT04613817

Sero-prevalence COVID-19 Among Belgian Children

An observational study of SARS-CoV-2 and SARS-CoV Infection, run by Sciensano at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 14 yearsHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2, SARS-CoV Infection, Covid19
How many people
2,103 participants
Where
1 siteBelgium
Study dates
3 Dec 2020to 31 Dec 2021
How long will I take part?
7 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: The study population includes primary and secondary school children from two predefined age groups. 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. Adolescents of 15 year and older will not be included as their symptom patterns resembles more disease pathology of adults. Because of pragmatic and practical reasons we will include primary school children from the 3rd grade (age 8-9) and secondary schoolchildren from the 2nd grade (age 13-14). The study sample will be recruited in all Belgian schools including Brussels-Capital, and the Flemish and Walloon Regions (including the German speaking community). School attendance in this age group is high in Belgium, because of this, recruitment of school-age children through schools is acceptable.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Sciensano

    Brussels, 1050

Other trials in Belgium

About this study

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

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.

Read more

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.

Keywords
SARS-CoV-2, COVID-19, Children, Belgium, Pandemic 2020
Medical subject headings
Severe Acute Respiratory Syndrome, COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of prevalence of antibodies against SARS-CoV-2 among Belgian children aged 8-9 years

    Change 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

    Measured: "Month 1", "Month 4", "Month 7", "Month 9" and "Month 11"

  2. Change of prevalence of antibodies against SARS-CoV-2 among Belgian children aged 8-9 years

    Change in the absolute numbers 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

    Measured: "Month 1", "Month 4", "Month 7", "Month 9" and "Month 11"

  3. Change of prevalence of antibodies against SARS-CoV-2 among Belgian children aged 13-14 years

    Change 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

    Measured: "Month 1", "Month 4" and "Month 7"

  4. Change of prevalence of antibodies against SARS-CoV-2 among Belgian children aged 13-14 years

    Change in the absolute numbers 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

    Measured: "Month 1", "Month 4" and "Month 7"

  5. Change in SARS-CoV-2 seroconversion among among Belgian children aged 8-9 years

    Change 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.

    Measured: "Month 4", "Month 7", "Month 9" and "Month 11"

  6. Change in SARS-CoV-2 seroconversion among among Belgian children aged 13-14 years

    Change 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.

    Measured: "Month 4" and "Month 7"

  7. Change in SARS-CoV-2 seroconversion among among Belgian children aged 8-9 years

    Change in the absolute number 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.

    Measured: "Month 4", "Month 7", "Month 9" and "Month 11"

  8. Change in SARS-CoV-2 seroconversion among among Belgian children aged 13-14 years

    Change in the absolute number 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.

    Measured: "Month 4" and "Month 7"

Secondary outcomes (3)

  1. Potential risk factors for the infection

    Proportion (%) 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).

    Measured: "Month 1", "Month 4", "Month 7", "Month 9" and "Month 11"

  2. The proportion of asymptomatic cases among new cases that develop during a period of 7 months

    Percentage of asymptomatic cases among new cases (positive serological test) that develop during a period of 7 months

    Measured: "Month 1", "Month 4", "Month 7", "Month 9" and "Month 11"

  3. The proportion of asymptomatic cases among new cases that develop during a period of 7 months

    Absolute number of asymptomatic cases among new cases (positive serological test) that develop during a period of 7 months

    Measured: "Month 1", "Month 4", "Month 7", "Month 9" and "Month 11"

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2020
  2. Study start3 Dec 2020
  3. Primary completion17 Dec 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,103 participants (actual)
Target duration
7 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04613817
Sponsor's protocol ID
SC_044A
Acronym
SeCoBelChild
Status last verified
Oct 2021
First submitted
30 Oct 2020
Last updated
13 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Callies M, Kabouche I, Desombere I, Merckx J, Roelants M, Vermeulen M, Duysburgh E. 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. BMC Public Health. 2023 May 16;23(1):898. doi: 10.1186/s12889-023-15806-5.

    PubMed 37194008

Questions about this trial

What is this clinical trial studying?

An observational study of SARS-CoV-2 and SARS-CoV Infection, run by Sciensano at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of prevalence of antibodies against SARS-CoV-2 among Belgian children aged 8-9 years (time frame: "Month 1", "Month 4", "Month 7", "Month 9" and "Month 11"). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04613817, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.

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