Dataset

Safety and immunogenicity of demi-dose of two Covid-19 mRNA vaccines in healthy population (REDU-VAC)- Dose 1 and 2

A collection of data (lab analysis and surveys) from a Belgian cohort of healthy people working at five sites across Belgium of the ‘External Department of Prevention and Protection at work’ of Mensura. Data are about participants' immunity previous and after COVID-19 vaccination (dose 1 and 2) using mRNA COVID-19 vaccine BTB162b2. Redu-VAC is a randomised, multicenter, non-inferiority study investigating safety, reactogenicity and immunogenicity of a fractional dose of the vaccine (20µg versus 30µg). Adverse events linked to the vaccination are available. Participants' survey with their health status is also available.

Overview

Keywords
COVID-19 Adverse events Immunology Vaccination Healthy population Reduced-dose
Languages
en
Health Categories
Data from clinical trials, clinical studies and clinical investigations subject to Regulation (EU) 536/2014, Regulation [SOHO], Regulation (EU) 2017/745 and Regulation (EU) 2017/746, respectively
Population Coverage
Healthy people
Provenance
  • Pseudonymised dataset, ethical approval granted
Documentation

Temporal Information

Temporal Coverage
Start
End
Update Frequency
NEVER
Metadata Dates
Issued:
Modified:

Spatial Information

Geographic Coverage
  • BE
NUTS Codes
http://data.europa.eu/nuts/code/BE

Additional Information

Dataset Types
Personal Data
Applicable Legislation
Legal Basis

  • Clinical Trial Regulation

    Source
HDAB
Contact Points
Conforms To
Structured Identifiers

Distributions & Resources

HDA request form

https://www.hda.belgium.be/en/data-request-form

Restricted en
Publication Info
License cc-zero1.0
Standards & Languages
Languages en
Conforms To
Distribution Profile
Direct Links
Access URL https://www.hda.belgium.be/en/data-request-form
COVID-19
Adverse events
Immunology
Vaccination
Healthy population
Reduced-dose