At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 80 enrolled
Drug / intervention
TDVbiological
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.
Impact of Subcutaneous Versus Intramuscular Administration of Inviragen's Live Attenuated Dengue Vaccine on Safety and Immunogenicity
In Brief
A Phase 1 clinical trial evaluating TDV for Dengue Fever. Completed, enrolled 80 participants across 1 site.
Detailed 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™).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDengue Fever
CountriesUnited States
CollaboratorsWalter Reed Army Institute of Research (WRAIR)
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2012
Enrollment StartJan 2013
Primary CompletionNov 2013
Study CompletionNov 2013
TodayJul 2026
First PostedNov 20, 2012
Enrollment StartJan 22, 2013
Primary CompletionNov 1, 2013
Study CompletionNov 21, 2013
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 13.6 years ago
Interventions
TDVbiological
TDV IM or SC injection