B/BE/18/BVW9 - Summary Notification Information Format (SNIF) Public information presented according to the provisions of Directive 2001/18/EC
Long title
Clinical trial RSV PED-011 entitled: “A Phase 1/2, randomized, observer-blind, controlled, multi-center study to evaluate safety, reactogenicity and immunogenicity of GSK Biologicals’ respiratory syncytial virus (RSV) investigational vaccine based on the RSV viral proteins F, N and M2-1 encoded by chimpanzee-derived adenovector (ChAd155-RSV) (GSK3389245A), when administered intramuscularly as a single dose or as two doses according to a 0, 1-month schedule, to infants aged 6 and 7 months.
Date receipt dossier
EU record number
B/BE/18/BVW9
EudraCT number
2018-000431-27
Company / Sponsor
GlaxoSmithKline Biologicals SA
Phase
I/II
Treated organism
Humans
Indication category
Vaccination
Disease
Lower respiratory tract infections
Therapeutic approach
Prevention
Genetic modification
Recombinant replication-defective simian (chimpanzee-derived) group C adenovirus viral vector construct engineered to express three proteins from the Respiratory Syncytial Virus (RSV)
Method of transfer of nucleic acid of interest
Recombinant replication-defective simian (chimpanzee-derived) group C adenovirus serotype 155 (ChAd155)
Administered biological material
Recombinant viruses
Route of administration
Intramuscular
Locations in Belgium
UZ Antwerpen, UZ Leuven
Nr of subjects
150
Foreseen duration
2 years starting from the 2nd quarter 2019
Type of procedure
Contained use and Deliberate release
Current status
Authorized