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NCT00319592 · ClinicalTrials.gov registry record · Phase 2
A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT00319592: Completed Phase 2 study, sponsored by Sanofi.
NCT00319592 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00319592, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
Immunogenicity was determined by analyzing antibody response of subjects to the respective homologous JE vaccine strain using a serum dilution 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as a 4 fold increase in antibody titer of ≥ 1:10 at baseline, or an antibody titer of ≥ 1:10 for participants with a baseline antibody titer of \< 1:10.
Interventions
- BIOLOGICAL ChimeriVax™-JE vaccine
- BIOLOGICAL JE-VAX® vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2005-05 |
| Est. Completion | 2006-09 |
| Phase | Phase 2 |
What the finished NCT00319592 record still lists
NCT00319592 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which ChimeriVax™-JE vaccine is the first listed.
NCT00319592 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00319592 about?
NCT00319592 is a clinical study titled "A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX". 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.
What is the current status of trial NCT00319592?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2005-05. Estimated completion is 2006-09.
What interventions are being tested in trial NCT00319592?
The interventions under investigation include: ChimeriVax™-JE vaccine (BIOLOGICAL), JE-VAX® vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00319592?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00319592's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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