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NCT03771963 · ClinicalTrials.gov registry record · Phase 3

Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) at the End of Shelf Life in Healthy Adults

A Phase 3 study, sponsored by Takeda.

Completed
Registry status
Phase 3
Development phase
200
Enrollment target

NCT03771963: Completed Phase 3 study, sponsored by Takeda.

NCT03771963 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 200 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03771963, a Phase 3 study, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 3
Development phase
200 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety and immune response of a naturally aged lot of tetravalent dengue vaccine (TDV) in healthy participants, aged 18 to 60 years, in non-endemic country(ies) for dengue.

Primary Outcome

GMTs of neutralizing antibodies for each of the 4 dengue serotypes were measured by microneutralization test 50% \[MNT50\]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3, and DENV-4.

Interventions

  • BIOLOGICAL Tetravalent Dengue Vaccine (TDV)

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2019-03-28
Est. Completion 2020-03-13
Phase Phase 3
Takeda

408 total trials

What the finished NCT03771963 record still lists

NCT03771963 is an interventional study that assigns participants to a tested intervention. The registered 200 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 (74% lower).

The record links to 0 conditions, and to 1 intervention - of which Tetravalent Dengue Vaccine (TDV) is the first listed.

NCT03771963 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03771963 about?

NCT03771963 is a clinical study titled "Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) at the End of Shelf Life in Healthy Adults". The purpose of this study is to evaluate the safety and immune response of a naturally aged lot of tetravalent dengue vaccine (TDV) in healthy participants, aged 18 to 60 years, in non-endemic country(ies) for dengue.

What is the current status of trial NCT03771963?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2019-03-28. Estimated completion is 2020-03-13.

What interventions are being tested in trial NCT03771963?

The interventions under investigation include: Tetravalent Dengue Vaccine (TDV) (BIOLOGICAL).

Who is sponsoring clinical trial NCT03771963?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03771963's enrollment target sits among peer trials

200 1353rd of 2000 higher than 613 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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Source: ClinicalTrials.gov NCT03771963, the US trial registry maintained by the National Library of Medicine. NCT03771963 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.