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NCT03342898 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Administered With a Yellow Fever Vaccine in Adults
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 900
- Enrollment target
NCT03342898: Completed Phase 3 study, sponsored by Takeda.
NCT03342898 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 900 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03342898, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 900 participants
- Enrollment target
Study Summary
The main purpose of this study is to assess the immunogenicity and safety of the concomitant and sequential administration of yellow fever (YF) vaccine and tetravalent dengue vaccine (TDV) in healthy participants aged 18 to 60 years living in country non-endemic for both dengue and YF.
Primary Outcome
Seroprotection was defined as reciprocal anti-YF neutralizing antibody titer ≥10. Immunological naivety to YF and DENV was defined as Baseline reciprocal neutralizing antibody titers \<10 for YF and for the 4 dengue serotypes. The 95% CI was calculated using exact Clopper-Pearson method.
Interventions
- DRUG Placebo
- BIOLOGICAL TDV
- BIOLOGICAL YF-17D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 900 participants |
| Start Date | 2018-02-28 |
| Est. Completion | 2019-05-22 |
| Phase | Phase 3 |
What the finished NCT03342898 record still lists
NCT03342898 is an interventional study that assigns participants to a tested intervention. The registered 900 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03342898 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03342898 about?
NCT03342898 is a clinical study titled "Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Administered With a Yellow Fever Vaccine in Adults". The main purpose of this study is to assess the immunogenicity and safety of the concomitant and sequential administration of yellow fever (YF) vaccine and tetravalent dengue vaccine (TDV) in healthy participants aged 18 to 60 years living in country non-endemic for both dengue and YF.
What is the current status of trial NCT03342898?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 900 participants. The study started on 2018-02-28. Estimated completion is 2019-05-22.
What interventions are being tested in trial NCT03342898?
The interventions under investigation include: Placebo (DRUG), TDV (BIOLOGICAL), YF-17D (BIOLOGICAL).
Who is sponsoring clinical trial NCT03342898?
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 NCT03342898's enrollment target sits among peer trials
900 350th of 2000 higher than 1,641 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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