Clinical Trial

Butantan-DV Vaccine in Elderly Populations (DEN-04-IB)

Study acronym: DEN-04-IB
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This is a randomized, double-blind (60 -79 years) and open-label (40-59 years), three-arm parallel Phase 3b, multicenter study to evaluate the safety and non-inferiority of the humoral immune response of the Butantan Dengue vaccine (Dengue 1,2,3,4 (attenuated)) in participants aged 60 -79 years (elderly) compared to participants aged 40 to 59 years (adults), with or without previous dengue and healthy based on clinical examination.
Protocol Amendment History 3 changes
notable Primary completion pushed: 2026-08 -> 2027-03 2026-07-17
minor Completion pushed: 2026-10 -> 2027-10 2026-07-17
notable Primary completion pushed: 2026-06 -> 2026-08 2026-07-10
Trial Details
NCT Number NCT06891950
Lead Sponsor Butantan Institute
Collaborators: Butantan Foundation
Conditions Dengue
Enrollment 997 participants
Start Date 2026-03-03
Primary Completion 2027-03 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-16