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Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
This study has been completed.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00314132
  Purpose

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.


Condition Intervention Phase
Encephalitis Virus, Vaccine
Biological: ChimeriVax-JE, Japanese Encephalitis vaccine
Phase III

MedlinePlus related topics: Encephalitis
Drug Information available for: Japanese Encephalitis Vaccines
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title: Randomised, Double Blind, Multicentre, Placebo Controlled Phase III Study of the Safety and Tolerability Following Administration of Live Attenuated JE Vaccine (ChimeriVax™-JE)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.strual period]).

Exclusion Criteria:

  • 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 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314132

Sponsors and Collaborators
Sanofi-Aventis
Investigators
Principal Investigator: Steven G Hull, MD Vince and Associates Clinical Research
  More Information

Study ID Numbers: H-040-010
Study First Received: April 11, 2006
Last Updated: April 24, 2007
ClinicalTrials.gov Identifier: NCT00314132  
Health Authority: United States: Food and Drug Administration;   Australia: Therapeutic Goods Administration

Study placed in the following topic categories:
Virus Diseases
Japanese encephalitis
Central Nervous System Infections
Central Nervous System Diseases
Encephalitis, Japanese
Arbovirus Infections
Brain Diseases
Encephalitis

Additional relevant MeSH terms:
Encephalitis, Viral
RNA Virus Infections
Flaviviridae Infections
Flavivirus Infections
Nervous System Diseases
Central Nervous System Viral Diseases
Encephalitis, Arbovirus

ClinicalTrials.gov processed this record on January 16, 2009