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

NCT06891950 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 997

Last updated 2026-03-06

No results posted yet for this study

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.

Conditions

  • Dengue

Interventions

BIOLOGICAL

Dengue 1,2,3,4 (attenuated) vaccine

Each 0.5 mL dose of the lyophilized formulation of Dengue 1,2,3,4 (attenuated) presents an approximate concentration of 103.0 PFU of each vaccine virus rDEN1Δ30-1545, rDEN2/4Δ30(ME)-1495,7163, rDEN3Δ30/31-7164, rDEN4Δ30-7132,7163,8308.

Sponsors & Collaborators

  • Fundação Butantan

    collaborator UNKNOWN

  • Butantan Institute

    lead OTHER_GOV

Principal Investigators

  • Fernanda C Boulos, MD, PhD · Instituto Butantan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-03
Primary Completion
2026-06-30
Completion
2026-10-31

Countries

  • Brazil

Study Locations

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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 NCT06891950 on ClinicalTrials.gov