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NCT02193087 · ClinicalTrials.gov registry record · Phase 2
Safety and Immunogenicity of Three Formulations of Takeda's Tetravalent Dengue Vaccine Candidate (TDV)
A Phase 2 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,002
- Enrollment target
NCT02193087: Completed Phase 2 study, sponsored by Takeda.
NCT02193087 is a Phase 2 study that has completed, run by Takeda. The registered enrollment target is 1,002 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (653% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02193087, a Phase 2 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,002 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the equivalence of the lyophilized formulation of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) compared with the liquid formulation of TDV.
Primary Outcome
Geometric mean titer (GMT) of neutralizing antibodies for each of the four dengue serotypes as measured by Plaque Reduction Neutralization Test resulting in 50% reduction in Plaques (PRNT50). The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4. A 90% Confidence Interval (CI) for the ratio of GMT (or equivalently the difference of the log transformed GMT) was provided, for each serotype, for the comparison of the lyophilized formulation (Group D) versus the liquid formulation 1 (Groups A
Interventions
- DRUG Placebo
- DRUG TDV Liquid Formulation 1
- DRUG TDV Liquid Formulation 2
- DRUG TDV IDT Lyophilized
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,002 participants |
| Start Date | 2014-08-06 |
| Est. Completion | 2015-05-19 |
| Phase | Phase 2 |
What the finished NCT02193087 record still lists
NCT02193087 is an interventional study that assigns participants to a tested intervention. Its 1,002 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (653% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02193087 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02193087 about?
NCT02193087 is a clinical study titled "Safety and Immunogenicity of Three Formulations of Takeda's Tetravalent Dengue Vaccine Candidate (TDV)". The purpose of this study is to evaluate the equivalence of the lyophilized formulation of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) compared with the liquid formulation of TDV.
What is the current status of trial NCT02193087?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,002 participants. The study started on 2014-08-06. Estimated completion is 2015-05-19.
What interventions are being tested in trial NCT02193087?
The interventions under investigation include: Placebo (DRUG), TDV Liquid Formulation 1 (DRUG), TDV Liquid Formulation 2 (DRUG), TDV IDT Lyophilized (DRUG).
Who is sponsoring clinical trial NCT02193087?
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 NCT02193087's enrollment target sits among peer trials
1,002 25th of 2000 higher than 1,976 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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