RANDOMISED, DOUBLE BLIND, MULTICENTRE,PLACEBO CONTROLLED PHASE III STUDY OF THE SAFETY AND TOLERABILITY FOLLOWING ADMINISTRATION OF LIVE ATTENUATED JE VACCINE (ChimeriVaxTM-JE)

Conditions: /A - Japanese Encephalitis Vaccine Study
N/A - Japanese Encephalitis Vaccine Study
Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Registration Number: ACTRN12605000575639

Lead Sponsor: PPD Development (Australia)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 2000

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety by the evaluation of adverse event incidence rates between the 2 treatment groups.[30 days after vaccination]

Secondary Outcome Measures

Name	Time	Method
1. The evaluation of AE incidence rates between treatment groups at intervals.[From Day 0 to 7, Day 0 to 14 and Day 0 to 30.];2. The evaluation of laboratory abnormalities between groups with respect to the normal reference ranges and changes in laboratory values.[From Baseline to Day 14 will be performed.];3. Safety will further be determined by summarising all Day 0 to 30 related AEs, SAEs, AEs leading to withdrawal, physical examinations and vital signs (including oral temperature).[]

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RANDOMISED, DOUBLE BLIND, MULTICENTRE,PLACEBO CONTROLLED PHASE III STUDY OF THE SAFETY AND TOLERABILITY FOLLOWING ADMINISTRATION OF LIVE ATTENUATED JE VACCINE (ChimeriVaxTM-JE)

Recruitment & Eligibility

Study & Design

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