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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)

NCT07712926 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1765

Last updated 2026-07-20

No results posted yet for this study

Summary

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.

Conditions

  • Dengue Fever With Warning Signs

Interventions

BIOLOGICAL

Butantan-DV (IB)

Butantan-DV manufactured at the Instituto Butantan - Butantan-DV (IB), mean 10³ PFU (per dose), subcutaneously, in the deltoid region.

BIOLOGICAL

Butantan-DV (WuXi)

Butantan-DV manufactured at the WuXi Biologics CRDMO - Butantan-DV (WuXi),mean 10³ PFU (per dose), subcutaneously, in the deltoid region.

OTHER

Placebo

Placebo manufactured at the Instituto Butantan - Placebo (IB), mean 0 PFU (per dose), subcutaneously, in the deltoid region.

Sponsors & Collaborators

  • Butantan Foundation

    collaborator OTHER

  • Butantan Institute

    lead OTHER_GOV

Principal Investigators

  • Fernanda C Boulos, MD, PhD · Instituto Butantan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2027-02-01
Primary Completion
2028-02-28
Completion
2028-12-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07712926 on ClinicalTrials.gov