Dossier withdrawn by the notifier

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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Dossier withdrawn by the notifier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Dossier withdrawn by the notifier on 12 August 2022