Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000576628
Ethics application status
Approved
Date submitted
29/09/2005
Date registered
4/10/2005
Date last updated
4/10/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
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®)
Scientific title
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®)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
N/A - Japanese Encephalitis Vaccine Study 703 0
Condition category
Condition code
Other 781 781 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Either single injection of study vaccine ChimeriVaxTM-JE (at Day 30) or 3 course injection (at Day 0, 7, and 30) with comparator vaccine (JE-VAX).
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 991 0
Noninferiority of ChimeriVaxTM-JE to JE-VAX, with the test intended to rule out a 5% difference in JE neutralising antibody seroconversion rates.
Timepoint [1] 991 0
Secondary outcome [1] 1877 0
1. The geometric mean neutralising antibody titres in the efficacy population.
Timepoint [1] 1877 0
30 days after a single dose of ChimeriVaxTM-JE or three doses of JE-VAX.
Secondary outcome [2] 1878 0
2. The ability of ChimeriVaxTM-JE to elicit an rapid immune response.
Timepoint [2] 1878 0
14 days after vaccination.
Secondary outcome [3] 1879 0
3. The evaluation of AE incidence between the ChimeriVaxTM-JE and the JE-VAX groups.
Timepoint [3] 1879 0

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Blinded study team. Non-blinded pharmacist prepares double blind study treatments and holds randomisation codes/lists.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated, block randomistion
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
816
Accrual to date
Final
Recruitment outside Australia
Country [1] 239 0
United Kingdom
State/province [1] 239 0

Funding & Sponsors
Funding source category [1] 859 0
Commercial sector/Industry
Name [1] 859 0
Acambis
Country [1] 859 0
Primary sponsor type
Commercial sector/Industry
Name
PPD Development (Australia)
Address
Country
Australia
Secondary sponsor category [1] 728 0
Commercial sector/Industry
Name [1] 728 0
Acambis
Address [1] 728 0
Country [1] 728 0
United Kingdom

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35455 0
Address 35455 0
Country 35455 0
Phone 35455 0
Fax 35455 0
Email 35455 0
Contact person for public queries
Name 9877 0
N/A
Address 9877 0
(We do not have an appropriate contact person for this study - individual sites will be using their own healthy volunteer databases/private practices together with local advertising measures to meet recruitment targets for the study)
Country 9877 0
Phone 9877 0
N/A
Fax 9877 0
Email 9877 0
N/A
Contact person for scientific queries
Name 805 0
John Stone
Address 805 0
Acambis Research Limited
Peterhouse Technology Park
100 Fulbourn Rd
Cambridge CB1 9PT
Country 805 0
United Kingdom
Phone 805 0
+44 (0)1223275300
Fax 805 0
Email 805 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.