A MULTICENTRE, RANDOMISED, DOUBLE BLIND, PHASE III STUDY OF THE COMPARATIVE IMMUNOGENICITY, SAFETY AND TOLERABILITY OF TWO JAPANESE ENCEPHALITIS VACCINES (ChimeriVaxTM-JE AND JE-VAX®)
- Conditions
- /A - Japanese Encephalitis Vaccine StudyN/A - Japanese Encephalitis Vaccine StudyOther - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
- Registration Number
- ACTRN12605000576628
- Lead Sponsor
- PPD Development (Australia)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 816
1. Written informed consent 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.
1. A history of vaccination or infection with JE or Yellow fever or other flaviviruses2. Previous or current military service3. History of residence in or travel to flavivirus endemic areas in the tropics for periods of 4 weeks or more4. Known or suspected immunodeficiency, use of immunosuppressive or antineoplastic drugs during the study5. History of thymoma, thymic surgery (removal) or myasthenia gravis6. Clin significant abnormalities on lab assessment7. Anaphylaxis or other serious adverse reactions to foods, Hymenoptera (bee family) stings, or drugs (including vaccines)8. 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 609. Administration of another vaccine or antiviral within 30 days preceding the Screening Visit or up to Day 6010. Physical exam indicating any clin significant med condition11. Oral temperature >38 degrees C or acute illness within 3 days prior to vaccination12. Seropositive to HCV or HIV or positive for Hepatitis B Surface Antigen13. Lactation or intended pregnancy in female subjects14. Excessive alcohol consumption, drug abuse, significant psychiatric illness15. A known or suspected physiological or structural condition that compromises the integrity of the blood-brain barrier16. A known hypersensitivity to constituents of JE-VAX including thimerosal, proteins of Rodent origin, neural tissue or gelatine17. Participation in another clinical study within 30 days of the screening visit for this study18. Employee of the study site, Sponsor or CRO involved with the management of the study19. Any other reasons, which in the investigators opinion, makes the subject unsuitable to participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method oninferiority of ChimeriVaxTM-JE to JE-VAX, with the test intended to rule out a 5% difference in JE neutralising antibody seroconversion rates.[]
- Secondary Outcome Measures
Name Time Method 1. The geometric mean neutralising antibody titres in the efficacy population.[30 days after a single dose of ChimeriVaxTM-JE or three doses of JE-VAX.];2. The ability of ChimeriVaxTM-JE to elicit an rapid immune response.[14 days after vaccination.];3. The evaluation of AE incidence between the ChimeriVaxTM-JE and the JE-VAX groups.[]