Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
Condition: Encephalitis; Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: ChimeriVax-JE, Japanese Encephalitis vaccine; 0.9% Saline
Intervention description: 0.5 mL, Subcutaneous; 0.5 mL, Subcutaneous
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2004.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Japanese Encephalitis; Encephalitis virus; ChimeriVax™-JE Vaccine

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 (dummy) vaccination.
    

Eligibility 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.

        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 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.