Long-Term Safety and Antibody Persistence of TDV and the Impact of a Booster Dose
Completed · Phase 3 · NCT03999996
Conditions: Dengue Fever
At a glance
- Research payments reported, 2025
- $231,638
- U.S. investigators named
- 8
- Sites paid
- 4
- Planned or actual enrollment
- 365
About the trial
- Sponsor
- Takeda
- Tested
- Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) (biological), Placebo (biological)
- Dates
- Started 2019-11-12; completion 2024-05-25
- Results posted
- Yes
The purpose of this study is to describe antibody persistence for each of the 4 dengue serotypes for up to 63 months after the first vaccination in the primary vaccination series for participants from parent trial DEN-315 (NCT03341637) (Mexico) and for up to 36 months after the first vaccination in the primary vaccination series for participants from parent trial DEN-304 (NCT03423173) (United States \[US\]) and to describe the impact of a tetravalent dengue vaccine (TDV) booster dose vs placebo on antibody response for each of the 4 dengue serotypes at 1 month and 6 months post administration of the TDV booster or placebo.
From ClinicalTrials.gov, last updated 2026-07-30. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Takeda Pharmaceuticals U.S.A., Inc. reported $231,638 in research payments for this study in 2025 (15 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Randle T. Middleton, M.D. Family Medicine · Huntsville, AL
- Daniel H. Brune, M.D. Family Medicine · Creve Coeur, IL
- Richard M. Glover II, MD Family Medicine · Newton, KS
- Melissa T. Choi, MD Family Medicine · St Louis Park, MN
- Leslie M. Tharenos, MD, MPH Occupational Medicine · Saint Louis, MO
- Lorrie L. Mcgill, MD Family Medicine · Papillion, NE
- Wayne Farnsworth, M.D. Emergency Medicine · Auburn, NY
- Barbara E. Rizzardi, MD Internal Medicine · Sandy, UT
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Optimal Research LLC $195,654
- Synexus Clinical Research US $27,300
- Alliance for Multispecialty Research LLC $4,640
- Velocity Clinical Research Inc $4,044
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.