A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX
Completed · Phase 3
Conditions studied: Japanese Encephalitis
In brief
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 after completion of vaccination course.
Key facts
- Study ID
- NCT00314145
- Run by
- Sanofi
- People needed
- 820
- Starts
- 2005-11-01
- Expected to finish
- 2006-11-01
- Last updated by the study team
- 2012-12-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subjects aged 18 or above
- Subjects in good general health.
- Females must have negative pregnancy test and be using adequate form of contraception
You may not qualify if…
- 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.
Where it is running
- Study site — Chicago, Illinois, United States
- Study site — Shawnee Mission, Kansas, United States
- Study site — Missoula, Montana, United States
- Study site — Dallas, Texas, United States
- Study site — Tacoma, Washington, United States
- Study site — Adelaide, Australia
- Study site — Melbourne, Australia
- Study site — New South Wales, Australia
- Study site — Queensland, Australia
- Study site — Victoria, Australia
Full record on ClinicalTrials.gov
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