At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 100 enrolled
Drug / intervention
4 µg TDENV-PIV with Alum adjuvant +4 morebiological
Likely dose
4 µg TDENV-PIV with Alum adjuvantfrom 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 Phase I, Randomized, Placebo-Controlled, Observer-blind, Two-dose (0-28 Day Schedule) Primary Vaccination Study of Walter Reed Army Institute of Research (WRAIR) Tetravalent Dengue Virus Purified Inactivated Vaccine (TDENV-PIV) in Healthy Adults in a Non-Endemic Region
U.S. Army Medical Research and Development Command·interventional·Posted Aug 16, 2012·Updated Jan 25, 2019
In Brief
A Phase 1 clinical trial evaluating 4 µg TDENV-PIV with Alum adjuvant, 1 µg TDENV-PIV with AS03B1 adjuvant, and 3 other interventions for Dengue Fever. Completed, enrolled 100 participants across 1 site.
Detailed Summary
The study is designed to afford a safety and immunogenicity assessment of three Tetravalent Dengue Virus-Purified Inactivated Vaccine(TDENV-PIV) vaccine candidates.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDengue Fever
CountriesUnited States
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2012
Enrollment StartSep 2012
Primary CompletionSep 2015
Study CompletionNov 2017
TodayJul 2026
First PostedAug 16, 2012
Enrollment StartSep 1, 2012
Primary CompletionSep 1, 2015
Study CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 13.9 years ago
Interventions
4 µg TDENV-PIV with Alum adjuvantbiological
1 µg TDENV-PIV with AS03B1 adjuvantbiological
Phosphate buffered salineother
1 µg TDENV-PIV with Alum adjuvantbiological
1 µg TDENV-PIV with AS01E1 adjuvantbiological