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A Study of Dengue Tetravalent Vaccine (TDV) in Adults (Age 45 to 60 and >60 to 79 Years)

StatusActive, Not Recruiting
PhasePhase 3
SponsorTakeda
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Eligibility criteria expanded, about 39 words · Secondary endpoints: details revised at 11 of 12 entries · Site details revised at 7 of 7 sites Show 3 more changesShow less
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: details revised at 11 of 12 entries
    • Site details revised at 7 of 7 sites
  2. Site details revised at 2 of 7 sitesv6
  3. Site details revised at 4 of 7 sitesv5
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 7 · Start date changed from estimate of Apr 1, 2026 to Jan 20, 2026v4 Show 2 more changesShow less
    • Study sites: 0 to 7
    • Start date changed from estimate of Apr 1, 2026 to Jan 20, 2026
  5. Primary and study completion dates: Mar 14, 2026 to Apr 14, 2027 Start date: Mar 17, 2025 to Apr 1, 2026v3 Show 1 more changeShow less
    • Start date: Mar 17, 2025 to Apr 1, 2026
  6. Study Status, Referencesv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Takeda
221 trials monitored
See 15 trials at risk
Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. Researchers have seen that dengue fever now also happens more often in elderly persons. The main aim of this study is to learn more about the side effects of TDV in adult (45 - 60 years) and elderly (60 - 79 years) persons and about TDV's ability to create an immune response in adult and elderly persons. Another aim is to learn about the side effects of TDV in adult and elderly persons in endemic countries who have one or more additional medical conditions (called comorbidities) such as diabetes mellitus, hypertension or a chronic kidney condition. In this study, participants will receive 2 vaccinations with TDV (the second 3 months after the first). During the study, participants will visit their study clinic 5 times.
Trial Details
NCT Number NCT06579755
Lead Sponsor Takeda
Conditions Dengue Fever
Enrollment 800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov