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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 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 365 participants.

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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.

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)

Trial Details

FieldValue
Enrollment Target 365 participants
Start Date 2019-11-12
Est. Completion 2024-05-25
Phase Phase 3

Sponsor

Takeda

408 total trials

What the Registry Record Tells You About NCT03999996

The ClinicalTrials.gov registry entry for NCT03999996 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 365 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03999996 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.