Phase 3b Trial To Evaluate Safety And Immune Response (Superiority) of a Two-Dose Butantan-DV Regimen And The Standard Single Dose In Dengue-Naive Children/Adolescents and Immune Response (Non-inferiority) in a Manufacturing Facility Change (DEN-06-IB)

This randomized, double-blind, three parallel-group, multicenter, phase 3b trial evaluates the safety and immunogenicity of Butantan-DV. The study compares two primary immunization regimens (Butantan-DV/Butantan-DV vs. Butantan-DV/Placebo) across both the 2-11 and 12-17 age cohorts. It also evaluates the manufacturing facility transition for the Butantan-DV dengue vaccine, by comparing the open-label arm WuXi Biologics (Butantan-DV group) to both double-blinded Butantan-DV/Butantan-DV and Butantan-DV/Placebo arms, in adolescents aged 12 to 17.

NCT Number	NCT07712926
Lead Sponsor	Butantan Institute Collaborators: Butantan Foundation
Conditions	Dengue Fever With Warning Signs
Enrollment	1,765 participants
Start Date	2027-02-01
Primary Completion	2028-02-28 (estimated)
Study Completion	2028-12-20 (estimated)
Updated on ClinicalTrials.gov	2026-07-20