At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 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.
An Open-Label, Phase 2 Trial to Investigate the Humoral and Cell-Mediated Immune Responses and Safety of a Tetravalent Dengue Vaccine Candidate (TDV) Administered Subcutaneously in Flavivirus-Naïve and Dengue-Immune Healthy Adults
In Brief
A Phase 2 clinical trial evaluating TDV for Dengue Fever. Completed, enrolled 30 participants across 2 sites.
Detailed Summary
The purpose of this study is to assess the neutralizing antibody response against each dengue serotype post-vaccination.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDengue Fever
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 2018
Enrollment StartDec 2018
Primary CompletionMar 2021
TodayJul 2026
First PostedNov 19, 2018
Enrollment StartDec 28, 2018
Primary CompletionMar 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7.6 years ago
Interventions
TDVbiological
TDV subcutaneous injection comprised of 1 molecularly characterized, attenuated dengue virus strain, and 3 chimeric dengue virus strains with potencies of not less than 3.3, 2.7, 4.0, and 4.5 log10 plaque forming units (PFU) per dose of TDV-1, TDV-2, TDV-3, and TDV-4, respectively.