# 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** · PHASE3 · NOT_YET_RECRUITING · sponsor: **Butantan Institute** · enrollment: 1765 (estimated)

## Conditions studied

- Dengue Fever With Warning Signs

## Interventions

- **BIOLOGICAL:** Butantan-DV (IB)
- **BIOLOGICAL:** Butantan-DV (WuXi)
- **OTHER:** Placebo

## Key facts

- **NCT ID:** NCT07712926
- **Lead sponsor:** Butantan Institute
- **Sponsor class:** OTHER_GOV
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** NOT_YET_RECRUITING
- **Start date:** 2027-02-01
- **Primary completion:** 2028-02-28
- **Final completion:** 2028-12-20
- **Target enrollment:** 1765 (ESTIMATED)
- **Last updated:** 2026-07-20

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07712926

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07712926, "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)". Retrieved via MORVS 2026-10-20 from https://api.morvs.ai/clinical/NCT07712926. Licensed CC0.

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