Study title:
A phase III, randomized observer blinded, placebo-controlled, multi-center study, to evaluate safety and immunogenicity of the Chikungunya vaccine MV-CHIK in healthy adults
Long title:
A phase III, randomized observer blinded, placebo-controlled, multi-center study, to evaluate safety and immunogenicity of the Chikungunya vaccine MV-CHIK in healthy adults
Date receipt dossier:
18 Feb 2020
EudraCT number:
2019-0035000-12
Pharmaceutical study code:
MV-CHIK
Company / Sponsor:
Themis Bioscience GmbH
Phase:
III
Treated organism:
Humans
Indication category:
Infectious disease
Disease:
Chikungunya fever
Therapeutic approach:
Prevention
Genetic modification:
Recombinant measles virus vaccine strain (Schwarz strain) expressing env (E1, E2, E3), capsid C en structural protein 6K from CHIKV
Method of transfer of nucleic acid of interest:
Not applicable
Administered biological material:
Recombinant measles virus vaccine strain (Schwarz strain) expressing E1, E2, E3, C, 6K protein from CHIKV
Route of administration:
Intramuscular
Locations in Belgium:
UZ Leuven, UZ Gent, U Antwerpen
Type of procedure:
Contained use only
Current status:
Authorized