At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 200 enrolled
Drug / intervention
Tetravalent Dengue Vaccine (TDV)biological
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.
An Open-Label, Phase 3 Trial to Investigate the Immunogenicity and Safety of Tetravalent Dengue Vaccine Candidate (TDV) at the End of Shelf Life in Healthy Adults in Non-Endemic Country(Ies) for Dengue
In Brief
A Phase 3 clinical trial evaluating Tetravalent Dengue Vaccine (TDV) for Dengue Fever. Completed, enrolled 200 participants across 2 sites.
Detailed Summary
The purpose of this study is to evaluate the safety and immune response of a naturally aged lot of tetravalent dengue vaccine (TDV) 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
20192020202120222023202420252026
First PostedDec 2018
Enrollment StartMar 2019
Primary CompletionOct 2019
Study CompletionMar 2020
TodayJul 2026
First PostedDec 11, 2018
Enrollment StartMar 28, 2019
Primary CompletionOct 14, 2019
Study CompletionMar 13, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.6 years ago
Interventions
Tetravalent Dengue Vaccine (TDV)biological
TDV SC injection.