SeCoBelChild: Sero-prevalence COVID-19 Among Belgian Children

Sponsor
Sciensano (Other)
Overall Status
Recruiting
CT.gov ID
NCT04613817
Collaborator
KU Leuven (Other), McGill University (Other)
1,640
Enrollment
1
Location
15.9
Anticipated Duration (Months)
103.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1640 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Dec 3, 2020
    Anticipated Primary Completion Date :
    Dec 30, 2021
    Anticipated Study Completion Date :
    Mar 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Change of prevalence of antibodies against SARS-CoV-2 among Belgian children aged 8-9 years ["Month 1", "Month 4", "Month 7", "Month 9" and "Month 11"]

      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

    2. Change of prevalence of antibodies against SARS-CoV-2 among Belgian children aged 8-9 years ["Month 1", "Month 4", "Month 7", "Month 9" and "Month 11"]

      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

    3. Change of prevalence of antibodies against SARS-CoV-2 among Belgian children aged 13-14 years ["Month 1", "Month 4" and "Month 7"]

      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

    4. Change of prevalence of antibodies against SARS-CoV-2 among Belgian children aged 13-14 years ["Month 1", "Month 4" and "Month 7"]

      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

    5. Change in SARS-CoV-2 seroconversion among among Belgian children aged 8-9 years ["Month 4", "Month 7", "Month 9" and "Month 11"]

      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.

    6. Change in SARS-CoV-2 seroconversion among among Belgian children aged 13-14 years ["Month 4" and "Month 7"]

      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.

    7. Change in SARS-CoV-2 seroconversion among among Belgian children aged 8-9 years ["Month 4", "Month 7", "Month 9" and "Month 11"]

      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.

    8. Change in SARS-CoV-2 seroconversion among among Belgian children aged 13-14 years ["Month 4" and "Month 7"]

      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.

    Secondary Outcome Measures

    1. Potential risk factors for the infection ["Month 1", "Month 4", "Month 7", "Month 9" and "Month 11"]

      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).

    2. The proportion of asymptomatic cases among new cases that develop during a period of 7 months ["Month 1", "Month 4", "Month 7", "Month 9" and "Month 11"]

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

    3. The proportion of asymptomatic cases among new cases that develop during a period of 7 months ["Month 1", "Month 4", "Month 7", "Month 9" and "Month 11"]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 14 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1SciensanoBrusselsBelgium1050

    Sponsors and Collaborators

    • Sciensano
    • KU Leuven
    • McGill University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sciensano
    ClinicalTrials.gov Identifier:
    NCT04613817
    Other Study ID Numbers:
    • SC_044A
    First Posted:
    Nov 3, 2020
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sciensano
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 8, 2021