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

Study acronym: DEN-04-IB
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion pushed from Aug 2026 to Mar 2027
    • Study completion pushed from Oct 2026 to Oct 2027
    v7
  2. Primary completion pushed from Jun 2026 to Aug 2026v6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2026 to Mar 3, 2026
    • Site details revised at 5 of 5 sites
    v5
  4. Start date: Nov 2025 to Jan 2026v4
  5. Start date: Jul 2025 to Nov 2025
    • Study sites: 1 to 5
    • Publications: details revised at 1 of 22 entries
    v3
  6. Start date: Apr 2025 to Jul 2025
    • Publications: details revised at 1 of 22 entries
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06891950
Lead Sponsor Butantan Institute
Collaborators: Butantan Foundation
Conditions
(from sponsor)		 Dengue
Related terms Dengue
Enrollment 997 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov