At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 1,002 enrolled
Drug / intervention
TDV Liquid Formulation 1 +3 moredrug
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.
A Randomized, Double Blind, Phase 2 Study to Assess the Safety and Immunogenicity of Three Formulations of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy Adults
In Brief
A Phase 2 clinical trial evaluating TDV Liquid Formulation 1, TDV Liquid Formulation 2, and 2 other interventions for Dengue Fever. Completed, enrolled 1,002 participants across 7 sites.
Detailed Summary
The purpose of this study is to evaluate the equivalence of the lyophilized formulation of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) compared with the liquid formulation of TDV.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDengue Fever
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 2014
Enrollment StartAug 2014
Primary CompletionMay 2015
TodayJul 2026
First PostedJul 17, 2014
Enrollment StartAug 6, 2014
Primary CompletionMay 19, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.0 years ago
Interventions
TDV Liquid Formulation 1drug
TDV Liquid Formulation 1 for subcutaneous injection
TDV Liquid Formulation 2drug
TDV Liquid Formulation 2 for subcutaneous injection
TDV IDT Lyophilizeddrug
TDV Lyophilized Formulation for subcutaneous injection
Placebodrug
TDV liquid formulation placebo-matching solution for subcutaneous injection