At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 67 enrolled
Drug / intervention
TDV +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1b, Partial-Blind, Parallel Group, Randomized Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine (DENVax) Administered Intradermally Using Needle or a Needle-Free PharmaJet® Injector in Healthy Adults
In Brief
A Phase 1 clinical trial evaluating TDV and Placebo for Healthy Volunteers. Completed, enrolled 67 participants across 2 sites.
Detailed Summary
The purpose of this study is to compare the safety, tolerability and immunogenicity of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\] when administered intradermally in varied dosing schedules and via different methods of administration (conventional needle/syringe versus needle-free PharmaJet® injector).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH)
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 2013
Enrollment StartFeb 2013
Primary CompletionJun 2014
TodayJul 2026
First PostedJan 10, 2013
Enrollment StartFeb 15, 2013
Primary CompletionJun 26, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.5 years ago
Interventions
TDVbiological
TDV suspension for intradermal administration
Placebodrug
Phosphate buffered saline (PBS)