At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 923 enrolled
Drug / intervention
TAK-003 +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.
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Demonstrate Lot-to-Lot Consistency of 3 Lots of a Tetravalent Dengue Vaccine Candidate in Healthy Adults in Non-Endemic Country(Ies) for Dengue
In Brief
A Phase 3 clinical trial evaluating TAK-003 and Placebo for Dengue Fever. Completed, enrolled 923 participants across 14 sites.
Detailed Summary
The purpose of this study is to investigate lot-to-lot consistency in terms of equivalence of the immune responses induced by 3 consecutive TDV lots in healthy participants aged 18 to 60 years in non-endemic country(ies) for dengue.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDengue Fever
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedFeb 2018
Enrollment StartFeb 2018
Primary CompletionAug 2018
Study CompletionJan 2019
TodayJul 2026
First PostedFeb 6, 2018
Enrollment StartFeb 12, 2018
Primary CompletionAug 3, 2018
Study CompletionJan 14, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.4 years ago
Interventions
TAK-003biological
TDV subcutaneous injection
Placebobiological
TDV Placebo-matching normal saline (0.9% NaCl) subcutaneous injection