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NCT01728792 · ClinicalTrials.gov registry record · Phase 1
Impact of SC vs IM Administration of DENVax (TDV) on Safety and Immunogenicity
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT01728792: Completed Phase 1 study, sponsored by Takeda.
NCT01728792 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01728792, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
This study assessed the safety and immunogenicity of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) previously referred to as DENVax of various dosing schedules via subcutaneous (SC) or intramuscular (IM) administration with needle/syringe or needle-free injector (PharmaJet Stratis™).
Primary Outcome
Injection site reactions were evaluated by the investigator within 14 days following each injection. Erythema (redness), edema (swelling/induration) and pain were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Pain was graded from 0=None to 4=Life-threatening. Erythema and Edema longest diameter were graded using the scale: 0=\<2.5 centimeters (cm) to 3=Severe: \>10 cm. Itching was grade
Interventions
- BIOLOGICAL TDV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2013-01-22 |
| Est. Completion | 2013-11-21 |
| Phase | Phase 1 |
What the finished NCT01728792 record still lists
NCT01728792 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 1 intervention - of which TDV is the first listed.
NCT01728792 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01728792 about?
NCT01728792 is a clinical study titled "Impact of SC vs IM Administration of DENVax (TDV) on Safety and Immunogenicity". This study assessed the safety and immunogenicity of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) previously referred to as DENVax of various dosing schedules via subcutaneous (SC) or intramuscular (IM) administration with needle/syringe or needle-free injector (PharmaJet Stratis™).
What is the current status of trial NCT01728792?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2013-01-22. Estimated completion is 2013-11-21.
What interventions are being tested in trial NCT01728792?
The interventions under investigation include: TDV (BIOLOGICAL).
Who is sponsoring clinical trial NCT01728792?
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 NCT01728792's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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