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

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Study 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
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: 
18 nov 2021
EudraCT number: 
2021-001909-77
Pharmaceutical study code: 
Ad26.RSV.preF
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