Open-label, Single-arm Phase 1 Study to Evaluate the Shedding, Biodistribution, Safety and Immunogenicity of Ad26.RSV.preF Vaccine in Adults

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Study title: 
Open-label, Single-arm Phase 1 Study to Evaluate the Shedding, Biodistribution, Safety and Immunogenicity of Ad26.RSV.preF Vaccine in Adults
Long title: 
Open-label, Single-arm Phase 1 Study to Evaluate the Shedding, Biodistribution, Safety and Immunogenicity of Ad26.RSV.preF Vaccine in Adults
Date receipt dossier: 
5 oct 2018
EudraCT number: 
2018-003261-34
Company / Sponsor: 
Janssen Vaccines & Prevention B.V.
Phase: 
I
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: 
Janssen Pharmaceutica N.V. (Jan Palfijn ziekenhuis)
Type of procedure: 
Contained use only
Current status: 
Under evaluation