Status:
COMPLETED
Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
Lead Sponsor:
Sanofi
Conditions:
Encephalitis
Japanese Encephalitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 (dumm...
Eligibility Criteria
Inclusion
- Informed consent obtained from the subject.
- Aged 18 years or above at screening.
- In good general health
- Subject available for the study duration
- For female subjects (of child bearing potential) a negative pregnancy tests at Screening and Day 0.
Exclusion
- A history of vaccination against or infection with JE.
- Known or suspected immunodeficiency, use of immunosuppressive or antineoplastic drugs.
- History of thymoma, thymic surgery (removal) or myasthenia gravis.
- Clinically significant abnormalities on laboratory assessment
- Anaphylaxis or other serious adverse reactions characterised by urticaria or angioedema to foods, Hymenoptera (bee family) stings, or drugs including vaccines).
- Transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit or up to Day 30.
- Administration of another vaccine or antiviral within 30 days preceding the Screening visit or up to Day 30.
- Physical examination indicating any clinically significant medical condition.
- Oral temperature \>38°C (100.4°F) or acute illness within 3 days prior to inoculation.
- Intention to travel out of the area for an extended period that may affect the subjects ability to attend clinic visits prior to the study visit up to Day 30.
- Seropositive to hepatitis C virus (HCV) or HIV or positive for Hepatitis B Surface Antigen.
- Lactation or intended pregnancy in female subjects.
- Excessive alcohol consumption, drug abuse, significant psychiatric illness.
- A known or suspected physiological or structural condition that compromises the integrity of the blood-brain barrier (e.g. cerebrovascular disease, multiple sclerosis, trauma, infection, inflammation of the brain or meninges).
- Participation in another clinical study within 30 days of the screening visit for this study.
- Employee of the study site, Sponsor or Clinical Research Organization (CRO) involved with the management of the study.
- Any other reasons, which in the investigator's opinion, makes the subject unsuitable to participate in the study.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
2004 Patients enrolled
Trial Details
Trial ID
NCT00314132
Start Date
October 1 2005
End Date
November 1 2006
Last Update
December 6 2012
Active Locations (22)
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1
Burbank, California, United States, 92505
2
Costa Mesa, California, United States, 92708
3
Davis, California, United States, 95616
4
San Francisco, California, United States, 94102