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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 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 140 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01542632
The ClinicalTrials.gov registry entry for NCT01542632 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01542632 reports 0 study locations.
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.
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