Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
NCT ID: NCT00314132
Last Updated: 2012-12-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2004 participants
INTERVENTIONAL
2005-10-31
2006-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo
All subjects received a single injection of placebo on Day 0.
0.9% Saline
0.5 mL, Subcutaneous
ChimeriVax™ JE 4 log10 PFU Vaccine
All participants received a single injection of ChimeriVax™ JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0.
ChimeriVax-JE, Japanese Encephalitis vaccine
0.5 mL, Subcutaneous
Interventions
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ChimeriVax-JE, Japanese Encephalitis vaccine
0.5 mL, Subcutaneous
0.9% Saline
0.5 mL, Subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Steven G Hull, MD
Role: PRINCIPAL_INVESTIGATOR
Vince and Associates Clinical Research
Locations
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Burbank, California, United States
Costa Mesa, California, United States
Davis, California, United States
San Francisco, California, United States
Vallejo, California, United States
Miami, Florida, United States
Orlando, Florida, United States
Pembroke Pines, Florida, United States
Iowa City, Iowa, United States
Overland Park, Kansas, United States
Bardstown, Kentucky, United States
Livonia, Michigan, United States
Sprnigfield, Missouri, United States
Omaha, Nebraska, United States
Winston-Salem, North Carolina, United States
Fort Worth, Texas, United States
Darlinghurst, , Australia
Enoggera, , Australia
Heidelbeg West, , Australia
Kippa-Ring, , Australia
Mill Park, , Australia
Toorak Gardens, , Australia
Countries
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References
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Torresi J, McCarthy K, Feroldi E, Meric C. Immunogenicity, safety and tolerability in adults of a new single-dose, live-attenuated vaccine against Japanese encephalitis: Randomised controlled phase 3 trials. Vaccine. 2010 Nov 23;28(50):7993-8000. doi: 10.1016/j.vaccine.2010.09.035. Epub 2010 Oct 8.
Other Identifiers
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H-040-010
Identifier Type: -
Identifier Source: org_study_id