Status:
COMPLETED
A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX
Lead Sponsor:
Sanofi
Conditions:
Japanese Encephalitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVaxTM-JE and JE-VAX to the respective homologous virus strain afte...
Eligibility Criteria
Inclusion
- Subjects aged 18 or above
- Subjects in good general health.
- Females must have negative pregnancy test and be using adequate form of contraception
Exclusion
- History of vaccination/infection with JE or Yellow fever or other flaviviruses
- History of residence/travel to flavivirus endemic regions
- History of anaphylaxis/serious adverse reactions
- Administration of vaccine within 30 days of study or during treatment period
- Clinically significant physical exam/medical history/lab abnormalities
- Pregnancy
- Excessive alcohol/drug abuse
- Hypersensitivity to constituents of JE-VAX®
- Blood transfusion/treatment with blood product within 6months of study and during study treatment period
- Known/suspected immunodeficiency
- Compromised blood brain barrier
- Employees of Clinical Research Organization (CRO)/study site staff
- Any other condition which would exclude subject.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
820 Patients enrolled
Trial Details
Trial ID
NCT00314145
Start Date
November 1 2005
End Date
November 1 2006
Last Update
December 6 2012
Active Locations (10)
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1
Chicago, Illinois, United States, 60610
2
Shawnee Mission, Kansas, United States, 66216
3
Missoula, Montana, United States, 59802
4
Dallas, Texas, United States, 75231