At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 138 enrolled
Drug / intervention
Inactivated, Dried, TSI-GSD 104, EEEbiological
Likely dose
Inactivated, Dried, TSI-GSD 104, EEE 0.5mlfrom 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 Multi-Site Phase 2 Open-Label, Safety and Immunogenicity Study of Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104 in Healthy Adults At Risk for Exposure to Eastern Equine Encephalitis Virus
U.S. Army Medical Research and Development Command·interventional·Posted Jan 2, 2008·Updated Sep 24, 2019
In Brief
A Phase 2 clinical trial evaluating Inactivated, Dried, TSI-GSD 104, EEE for Eastern Equine Encephalitis. Completed, enrolled 138 participants across 1 site.
Detailed Summary
This study is designed to determine the safety and immunogenicity of Eastern Equine Encephalitis (EEE) Vaccine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEastern Equine Encephalitis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2008
Enrollment StartJun 2008
Primary CompletionJun 2016
Study CompletionJun 2017
TodayJul 2026
First PostedJan 2, 2008
Enrollment StartJun 3, 2008
Primary CompletionJun 27, 2016
Study CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 18.5 years ago
Interventions
Inactivated, Dried, TSI-GSD 104, EEEbiological
Subjects will receive 0.5ml SQ, as a two-dose primary series (days 0 and 28) and 0.1ml, as a mandatory booster dose at 6 months. A booster dose may be administered before 6 months if PRNT80 is \< 1:40 after day 28. Up to four booster doses may be given in any 1-year period.