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NCT03999996 · ClinicalTrials.gov registry record · Phase 3
Long-Term Safety and Antibody Persistence of TDV and the Impact of a Booster Dose
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 365
- Enrollment target
NCT03999996: Completed Phase 3 study, sponsored by Takeda.
NCT03999996 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 365 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03999996, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 365 participants
- Enrollment target
Study Summary
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.
Primary Outcome
GMTs of neutralizing antibodies were measured by microneutralization test 50% (MNT50) for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 1 at Month 0 for participants from both parent trials (DEN-304 and DEN-315).
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 365 participants |
| Start Date | 2019-11-12 |
| Est. Completion | 2024-05-25 |
| Phase | Phase 3 |
What the finished NCT03999996 record still lists
NCT03999996 is an interventional study that assigns participants to a tested intervention. The registered 365 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03999996 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03999996 about?
NCT03999996 is a clinical study titled "Long-Term Safety and Antibody Persistence of TDV and the Impact of a Booster Dose". 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 ...
What is the current status of trial NCT03999996?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 365 participants. The study started on 2019-11-12. Estimated completion is 2024-05-25.
What interventions are being tested in trial NCT03999996?
The interventions under investigation include: Placebo (BIOLOGICAL), Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03999996?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03999996's enrollment target sits among peer trials
365 1001st of 2000 higher than 998 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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