Long title
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Safety and Immunogenicity of an Ad26,RSV,preF-based Vaccine in Adults Aged 18 to 59 years, Including Those at High-risk for severe RSV
Date receipt dossier
EudraCT number
2021-001909-77
Company / Sponsor
Janssen Vaccines & Prevention B.V.
Phase
III
Treated organism
Humans
Indication category
Infectious disease
Disease
Acute respiratory illness caused by RSV
Therapeutic approach
Prevention
Genetic modification
Replication deficient Adenovirus serotype 26 containing a deoxyribonucleic acid (DNA) transgene that encodes the pre-fusion conformation-stabilized F protein (pre-F) derived from the RSV A2 strain
Method of transfer of nucleic acid of interest
not applicable
Administered biological material
Recombinant replication deficient adenovirus serotype 26 (Ad26.RSV.preF)
Route of administration
Intramuscular
Locations in Belgium
ANIMA Research Center (ARC), Alken; Pneumocre SRL/RespiSom (Namur); CHU Saint-Pierre
Type of procedure
Contained use only
Current status
Authorized
Pharmaceutical study code
Ad26.RSV.preF