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Study identifier: NCT06891950 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Dengue  ·  Sponsor: Butantan Institute

PhasePhase 3
Planned participants997
Who can joinAll sexes, 40 Years to 79 Years
Healthy volunteersYes

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Fabiano Ramos, MD, PhD  ·  +55(51) 3320-5610  ·  framos@pucrs.br

Always discuss trial participation with your own doctor first.

Locations (5)

CWB 02 - Centro Médico São FranciscoCuritiba, Paraná, BrazilRecruiting
PET 01 - Hospital Escola da Universidade de Pelotas - HEUFPELPelotas, Rio Grande do Sul, BrazilRecruiting
POA 05 - Núcleo de Pesquisa do Rio Grande do SulPorto Alegre, Rio Grande do Sul, BrazilRecruiting
POA 02 - Associação Hospitalar Moinhos de VentoPorto Alegre, Rio Grande do Sul, BrazilRecruiting
POA 01 - Centro de Pesquisa: Hospital São Lucas - PUCRSPorto Alegre, Rio Grande do Sul, BrazilRecruiting

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Source record: clinicaltrials.gov/study/NCT06891950