Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.

• Number of Participants Reporting Treatment Related Adverse Events Post Vaccination With Either ChimeriVax™-JE or a Placebo [ Time Frame: Day 0 up to 30 days post-vaccination ] [ Designated as safety issue: No ]
  Adverse events were collected by means of diary cards and scripted interviews. All adverse events reporting was considered "actively solicited" through Day 30.
• Number of Participants Reporting Treatment Emergent Local Adverse Reactions and Treatment Emergent Systemic Reactions Post-vaccination With Either ChimeriVax™-JE or a Placebo [ Time Frame: Day 0 up to 30 days post-vaccination ] [ Designated as safety issue: No ]

  Treatment emergent local adverse reactions: Injection Site Pain, Itching, Erythema, Swelling, Induration, Skin Rash, and others as reported.

  Treatment emergent systemic reactions: Malaise, Headache, Myalgia, Feeling Hot, Chills, Fatigue, Dyspnea, Wheezing, Nausea, Vomiting, Diarrhea, Abdominal Pain and others as reported.

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.

• Encephalitis
• Japanese Encephalitis

• Biological: ChimeriVax-JE, Japanese Encephalitis vaccine
  0.5 mL, Subcutaneous
  Other Name: ChimeriVax™
• Biological: 0.9% Saline
  0.5 mL, Subcutaneous

• Placebo Comparator: Placebo
  All subjects received a single injection of placebo on Day 0.
  Intervention: Biological: 0.9% Saline
• Experimental: 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.
  Intervention: Biological: ChimeriVax-JE, Japanese Encephalitis vaccine

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.