The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial with the genetically modified ChAd155-RSV vaccine from the company GlaxoSmithKline Biologicals. The purpose of this trial is to provide critical information on the safety, reactogenicity and immunogenicity profile of the ChAd155-RSV vaccine in infants, as well as on the risk of vaccine-induced enhanced RSV disease after vaccination. The public consultation runs from 26 November 2018 to 26 December 2018 inclusive.
GSK Biologicals develops the paediatric ChAd155-RSV vaccine to protect infants from respiratory syncytial virus (RSV) infections. The ChAd155-RSV vaccine is a viral suspension (or viral vector construction) designed to express three proteins from the respiratory syncytial virus (RSV).
During the clinical trial, the ChAd155-RSV vaccine is administered intramuscularly as a single or as two doses, to infants aged 6 and 7 months who are likely to be unexposed to RSV.
The clinical trial will be conducted at the Antwerp University Hospital and the Leuven University Hospital.
As a citizen of Belgium you can comment on this clinical trial application.
For each clinical trial application related to the use of genetically modified organisms, the authority organises a public consultation for 30 days (in accordance with the Royal Decree of 21 February 2005).
You will have access to the data in the application file, as well as to an on-line form (in Dutch and French) to send comments or ask questions about this file.
The public consultation will last until 26 December 2018 inclusive.