None listed
Conditions
Interventions
Single injection of either study vaccine ChimeriVaxTM-JE
Sponsors
PPD Development (Australia)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent obtained 2. In good general health 3. Available for the study duration 4. For female subjects: Negative pregnancy tests at Screening and Day 0, Females of childbearing potential will be required to be correctly using an efficacious hormonal method of contraception or intrauterine device for at least 1 month before randomisation and during the on-study phase to Day 30.
Exclusion criteria
1. A history of vaccination against or infection with JE2. Known or suspected immunodeficiency, use of immunosuppressive or antineoplastic drugs during the study3. History of thymoma, thymic surgery (removal) or myasthenia gravis4. Clinically significant abnormalities on laboratory assessment5. Anaphylaxis or other serious adverse reactions to foods, Hymenoptera (bee family) stings, or drugs (including vaccines).6. 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 307. Administration of another vaccine or antiviral within 30 days preceding the Screening Visit or up to Day 308. Physical examination indicating any clin significant med condition9. Oral temperature >38 degrees C or acute illness within 3 days prior to vaccination10. Seropositive to HCV or HIV or positive for Hepatitis B Surface Antigen11. Lactation or intended pregnancy in female subjects12. Excessive alcohol consumption, drug abuse, significant psychiatric illness13. A known or suspected physiological or structural condition that compromises the integrity of the blood-brain barrier14. Participation in another clinical study within 30 days of the screening visit for this study15. Employee of the study site, Sponsor or CRO involved with the management of the study16. Any other reasons, which in the investigators opinion, makes the subject unsuitable to participate in the study.
Outcome results
None listed