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 November, 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