Study title:
Dossier withdrawn by the notifier
Long title:
A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Three Different Potency Levels of V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [live, attenuated]) in Healthy Adults
Date receipt dossier:
2 Feb 2022
EU record number:
B/BE/21/BVW9
EudraCT number:
2020-004501-30
Company / Sponsor:
ActoGenix
Phase:
II
Treated organism:
Humans
Indication category:
Vaccination
Disease:
Dengue disease
Therapeutic approach:
Prevention
Genetic modification:
V181 is a live attenuated dengue quadrivalent vaccine rDENVΔ30 where the four viral components of V181 (one for each serotype) present a deletion of 30 nucleotides in the 3’ non‐coding region (Δ30)
Method of transfer of nucleic acid of interest:
N/A
Administered biological material:
Attenuated virus
Route of administration:
Subcutaneous
Locations in Belgium:
UZ Gent, CHU Saint-Pierre Brussels, Instituut voor Tropische Geneeskunde Antwerpen, ANIMA Research Center Alken
Nr of subjects:
Up to 185 patients in Belgium
Foreseen duration:
From 09 August 2022 till 12 August 2025
Type of procedure:
Contained use and Deliberate release
Notes:
Dossier withdrawn by the notifier on 12 August 2022