A study to evaluate safety, reactogenicity and immunogenicity of GSK Biologicals’ RSV investigational vaccine based on viral proteins encoded by chimpanzee-derived adenovector (ChAd155-RSV) (GSK3389245A) in infants.

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Study title: 
A study to evaluate safety, reactogenicity and immunogenicity of GSK Biologicals’ RSV investigational vaccine based on viral proteins encoded by chimpanzee-derived adenovector (ChAd155-RSV) (GSK3389245A) in infants.
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: 
21 nov 2018
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

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