At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 60 enrolled
Drug / intervention
ChimeriVax™-JE vaccine +1 morebiological
Likely dose
ChimeriVax™-JE vaccine 0.5 mLfrom 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.
Randomized, Double-blind, Phase II Study of the Safety, Tolerability and Immunogenicity Following Administration of Live Attenuated JE Vaccine (ChimeriVax™ JE) Compared With Mouse Brain-derived Inactivated JE Vaccine (JE VAX®).
In Brief
A Phase 2 clinical trial evaluating ChimeriVax™-JE vaccine and JE-VAX® vaccine for Japanese Encephalitis. Completed, enrolled 60 participants across 1 site.
Detailed Summary
The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVax™-JE and JE-VAX® to the respective homologous virus strain and several wild types strains after completion of vaccination course.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJapanese Encephalitis
CountriesUnited States
CollaboratorsPRA Health Sciences
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2005
First PostedApr 2006
Primary CompletionSep 2006
TodayJul 2026
First PostedApr 27, 2006
Enrollment StartMay 1, 2005
Primary CompletionSep 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.2 years ago
Interventions
ChimeriVax™-JE vaccinebiological
0.5 mL, subcutaneously
JE-VAX® vaccinebiological
1.0 mL, subcutaneously