NCT05373420

Brief Summary

In January 2021, the vaccination campaign against coronavirus disease 2019 (COVID-19) started in Belgium. The vaccination campaign was conducted in several phases, with the first phase targeting priority groups starting in January 2021. The second phase began in June 2021 with the invitation of everyone aged 18 years and older before extending access to 12 years and older from summer 2021. Children aged 5-11 were also invited for vaccination from December 2021 onwards. The presence of a social gradient in COVID-19 infections and subsequent outcomes has been clearly demonstrated. Individuals from lower socioeconomic groups, for example with lower income, lower education level or unemployed are more likely to be infected by the SARS-CoV-2 and to develop severe complications after the infection such as hospitalization, ICU admission or death. Certain sociodemographic characteristics such as male gender, older age, living in crowded households, or belonging to ethnic/racial minorities are also associated with a higher risk of COVID-19 infection and severe outcomes. In addition to disparities in infection, hospitalization and mortality, some studies have also documented a lower COVID-19 vaccination coverage among people from disadvantaged socioeconomic groups during COVID-19 pandemic. Despite widespread vaccine promotion efforts and the fact that Belgium has the 7th highest full vaccine coverage in the European Union (89% of people over 18 years old had completed their primary course of vaccination on 08 April 2022), concerns regarding vaccine equity remain. Vaccine uptake depends on a range of factors, including the socio-cultural environment, pre-existing health needs and individual choice. Identifying differences in vaccination between population groups is crucial to assess the effectiveness of the vaccination strategy in Belgium and its relationship to the further spread of COVID-19. The objective is to identify whether vaccination coverage has been equitable across Belgium and, if not, which groups of individuals are less likely to be covered by the COVID-19 vaccine, with respect to their sociodemographic (SD) and socioeconomic (SE) characteristics. This study therefore aims to highlight SD and SE disparities in the uptake of the first dose of COVID-19 vaccine in Belgium among people of 18 years and over.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,341,584

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 28, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
Last Updated

June 3, 2022

Status Verified

March 1, 2022

Enrollment Period

8 months

First QC Date

May 12, 2022

Last Update Submit

May 31, 2022

Conditions

Keywords

COVID-19Vaccinationsocioeconomic factorssociodemographic factorsInequity

Outcome Measures

Primary Outcomes (1)

  • Number of participants who received the first dose of COVID-19 vaccine

    Uptake of the first COVID-19 vaccine dose until the 31st of August 2021 in Belgium

    28 December 2020 - 31 August 2021

Study Arms (1)

All individuals tested for COVID-19 in Belgium

All individuals of 18 years old and over tested for COVID-19 at least once in Belgium until the 31st of August 2021

Other: Education levelOther: Household net incomeOther: GenderOther: Migration backgroundOther: Household typeOther: Health literacy

Interventions

Educational level was classified using the International Standard Classification of Education (ISCED) : ISCED0 (less than primary education), ISCED1 (primary education), ISCED2 (lower secondary school), ISCED3 (upper secondary school), ISCED4 (post-secondary non tertiary education), ISCED5 (short-cycle tertiary education), ISCED6 (bachelor's or equivalent level), ISCED7 (master's or equivalent level), ISCED8 (doctoral or equivalent level). We merged these different categories into three main education level : low (ISCED0 to ISCED2), middle (ISCED3 to ISCED4) and high (ISCED5 to ISCED 8). This information is provided by STATBEL.

All individuals tested for COVID-19 in Belgium

Income information is available as deciles of the net income of the whole household. This indicator is further categorized into low income (deciles 1 to 4), middle income (deciles 5 to 7), and high income (deciles 8 to 10). This information is provided by STATBEL.

All individuals tested for COVID-19 in Belgium
GenderOTHER

Male or female. This variable is obtained from the Belgian national registry.

All individuals tested for COVID-19 in Belgium

Migration background is based on the first nationality and the parents' country of origin. This variable distinguishes between native-born individuals, second-generation migrants, first-generation European migrants, and first-generation non-European migrants. This information is provided by STATBEL.

All individuals tested for COVID-19 in Belgium

Household type provides a partial picture of the social environment and is distinguished between one person, couples, couples with children, single parents, other, collectivity (prison, nursing homes, religious community, etc.). This information is provided by STATBEL.

All individuals tested for COVID-19 in Belgium

Having a health care degree is used as a proxy for health literacy and is provided by CoBRHA. The scientific and medical background can lead to more preventive and responsible behaviors towards infectious diseases. Moreover, being a health professional can lead to the need to protect patients and themselves against infections, without necessarily having very advanced knowledge of infectious diseases and vaccines.

All individuals tested for COVID-19 in Belgium

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All individuals of 18 years and over tested for COVID-19 at least once in Belgium before 31 August 2021

You may qualify if:

  • Tested at least once in Belgium before 31 August 2021

You may not qualify if:

  • people with a national registry status equivalent to deceased
  • people with a national registry status equivalent to migrated
  • people with a national registry status equivalent to deregistered
  • people with an unknown age
  • people with an unknown gender
  • people with an unknown region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lisa Cavillot

Brussels, 1000, Belgium

Location

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

Educational StatusSexHealth Literacy

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsReproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaConsumer Health InformationHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Lucy LC Catteau, PhD

    Sciensano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2022

First Posted

May 13, 2022

Study Start

December 28, 2020

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

June 3, 2022

Record last verified: 2022-03

Locations