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NCT00314132 · ClinicalTrials.gov registry record · Phase 3
Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
A Phase 3 study of Encephalitis and Japanese Encephalitis, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,004
- Enrollment target
- 20
- Study locations
NCT00314132: Completed Phase 3 study of Encephalitis and Japanese Encephalitis, sponsored by Sanofi.
NCT00314132 is a Phase 3 study of Encephalitis and Japanese Encephalitis that has completed, run by Sanofi. The registered enrollment target is 2,004 participants, above the 292-participant average among 4 other Encephalitis trials with a reported enrollment target (586% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00314132, a Phase 3 study of Encephalitis and Japanese Encephalitis, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,004 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess whether ChimeriVax™ JE vaccine (a new vaccine to be used for vaccination against Japanese encephalitis) is safe and well tolerated when compared to placebo (dummy) vaccination.
Primary Outcome
Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered "actively solicited" through Day 30.
Conditions Studied
Interventions
- BIOLOGICAL ChimeriVax-JE, Japanese Encephalitis vaccine
- BIOLOGICAL 0.9% Saline
Study Locations (20)
California
- - Burbank
- - Costa Mesa
- - Davis
- - San Francisco
- - Vallejo
Other
- - Darlinghurst
- - Enoggera
- - Heidelbeg West
- - Kippa-Ring
Florida
- - Miami
- - Orlando
- - Pembroke Pines
Iowa
- - Iowa City
Kansas
- - Overland Park
Kentucky
- - Bardstown
Michigan
- - Livonia
Missouri
- - Sprnigfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,004 participants |
| Start Date | 2005-10 |
| Est. Completion | 2006-11 |
| Phase | Phase 3 |
What the finished NCT00314132 record still lists
NCT00314132 is an interventional study that assigns participants to a tested intervention. Its 2,004 participants enrollment target places it among the larger protocols in the corpus, above the 292-participant average among 4 other Encephalitis trials with a reported enrollment target (586% higher).
The record links to 2 conditions, with Encephalitis appearing as the primary indexed condition, and to 2 interventions - of which ChimeriVax-JE, Japanese Encephalitis vaccine is the first listed.
NCT00314132 names 20 study sites across 11 states, led by California, Other, Florida.
Frequently Asked Questions
What is clinical trial NCT00314132 about?
NCT00314132 is a clinical study titled "Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.". The purpose of this study is to assess whether ChimeriVax™ JE vaccine (a new vaccine to be used for vaccination against Japanese encephalitis) is safe and well tolerated when compared to placebo (dummy) vaccination.
What is the current status of trial NCT00314132?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,004 participants. The study started on 2005-10. Estimated completion is 2006-11.
What conditions does trial NCT00314132 study?
This clinical trial studies the following conditions: Encephalitis, Japanese Encephalitis.
What interventions are being tested in trial NCT00314132?
The interventions under investigation include: ChimeriVax-JE, Japanese Encephalitis vaccine (BIOLOGICAL), 0.9% Saline (BIOLOGICAL).
Who is sponsoring clinical trial NCT00314132?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00314132 being conducted?
This trial has 20 study locations across California, Florida, Iowa, Kansas, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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