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NCT01542632 · ClinicalTrials.gov registry record · Phase 1
A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 140
- Enrollment target
NCT01542632: Completed Phase 1 study, sponsored by Takeda.
NCT01542632 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 140 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (133% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01542632, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 140 participants
- Enrollment target
Study Summary
A Phase 1 study to compare the safety, tolerability and immunogenicity of different dose schedules of subcutaneously (SC) administered dengue vaccine in healthy adults and to compare the immunogenicity of different dose schedules of the vaccine. Blood samples were obtained for safety labs on Days 0, 7, 14, 90, 97, 104 and measurement of viremia at baseline \[during the screening period or on day of vaccination (Day 0)\], and then on Days 7, 9, 11, 14, 17, 21, 90, 97, and 104. Blood samples for measurement of dengue neutralizing antibodies in serum were obtained at baseline \[during the screening period or on day of vaccination (Day 0)\], then on Days 30, 90 and 120. The entire duration for each individual subjects participation was approximately 5 months including recruitment and collection of data for primary outcomes (through Day 120).
Primary Outcome
Erythema and Edema Were Graded Per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Where Grade 0=none to Grade 4=Severe. Pain and Itching were graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where Grade 0=no pain or itching to Grade 4= Life-threatening/severe. Only those score categories for which there was at least 1 participant are reported.
Interventions
- DRUG Placebo
- BIOLOGICAL Takeda's Tetravalent Dengue Vaccine Candidate (TDV)
- BIOLOGICAL TDV New Formulation
- DRUG New Formulation Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2012-02-01 |
| Est. Completion | 2014-01-10 |
| Phase | Phase 1 |
What the finished NCT01542632 record still lists
NCT01542632 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (133% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01542632 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01542632 about?
NCT01542632 is a clinical study titled "A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers". A Phase 1 study to compare the safety, tolerability and immunogenicity of different dose schedules of subcutaneously (SC) administered dengue vaccine in healthy adults and to compare the immunogenicity of different dose schedules of the vaccine. Blood samples were obtained for safety labs on Days 0...
What is the current status of trial NCT01542632?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 140 participants. The study started on 2012-02-01. Estimated completion is 2014-01-10.
What interventions are being tested in trial NCT01542632?
The interventions under investigation include: Placebo (DRUG), Takeda's Tetravalent Dengue Vaccine Candidate (TDV) (BIOLOGICAL), TDV New Formulation (BIOLOGICAL), New Formulation Placebo (DRUG).
Who is sponsoring clinical trial NCT01542632?
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 NCT01542632's enrollment target sits among peer trials
140 402nd of 2000 higher than 1,583 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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