Study title:
A randomized, double-blind, placebo-controlled Phase 1/2a study to evaluate the safety, reactogenicity, and immunogenicity of Ad26COVS1 in adults aged 18 to 65 years, inclusive and adults aged 65 years and older.
Long title:
A randomized, double-blind, placebo-controlled Phase 1/2a study to evaluate the safety, reactogenicity, and immunogenicity of Ad26COVS1 in adults aged 18 to 65 years, inclusive and adults aged 65 years and older.
Date receipt dossier:
25 juin 2020
EU record number:
J&JBE-018_004
EudraCT number:
2020-001483-28
Pharmaceutical study code:
Ad26-COVID19
Company / Sponsor:
Janssen Vaccines & Prevention B.V.
Phase:
I/II a
Treated organism:
Humans
Indication category:
Infectious disease
Disease:
COVID-19
Therapeutic approach:
Prevention
Genetic modification:
Recombinant Adenoviral vector serotype 26 expressing the spike glycoprotein 1 from SARS-CoV2
Method of transfer of nucleic acid of interest:
Not applicable
Administered biological material:
Recombinant Adenoviral vector serotype 26 expressing the spike glycoprotein 1 from SARS-CoV2
Route of administration:
Intramuscular
Locations in Belgium:
Janssen Pharmaceutica N.V., Clinical Pharmacology Unit (Jan Palfijn ziekenhuis)
Type of procedure:
Contained use only
Current status:
Under evaluation