Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000575639
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
RANDOMISED, DOUBLE BLIND, MULTICENTRE,
PLACEBO CONTROLLED PHASE III STUDY OF THE SAFETY AND TOLERABILITY FOLLOWING ADMINISTRATION OF LIVE ATTENUATED JE VACCINE (ChimeriVaxTM-JE)
Scientific title
RANDOMISED, DOUBLE BLIND, MULTICENTRE,
PLACEBO CONTROLLED PHASE III STUDY OF THE SAFETY AND TOLERABILITY FOLLOWING ADMINISTRATION OF LIVE ATTENUATED JE VACCINE (ChimeriVaxTM-JE)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
N/A - Japanese Encephalitis Vaccine Study 702 0
Condition category
Condition code
Other 780 780 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
Single injection of either study vaccine ChimeriVaxTM-JE
Comparator / control treatment
Placebo (saline)
Control group
Placebo

Outcomes
Primary outcome [1] 990 0
Safety by the evaluation of adverse event incidence rates between the 2 treatment groups.
Timepoint [1] 990 0
30 days after vaccination
Secondary outcome [1] 1874 0
1. The evaluation of AE incidence rates between treatment groups at intervals.
Timepoint [1] 1874 0
From Day 0 to 7, Day 0 to 14 and Day 0 to 30.
Secondary outcome [2] 1875 0
2. The evaluation of laboratory abnormalities between groups with respect to the normal reference ranges and changes in laboratory values.
Timepoint [2] 1875 0
From Baseline to Day 14 will be performed.
Secondary outcome [3] 1876 0
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).
Timepoint [3] 1876 0

Eligibility
Key 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.
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 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
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
Safety
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
2000
Accrual to date
Final
Recruitment outside Australia
Country [1] 238 0
United Kingdom
State/province [1] 238 0

Funding & Sponsors
Funding source category [1] 858 0
Commercial sector/Industry
Name [1] 858 0
Acambis
Country [1] 858 0
Primary sponsor type
Commercial sector/Industry
Name
PPD Development (Australia)
Address
Country
Australia
Secondary sponsor category [1] 727 0
Commercial sector/Industry
Name [1] 727 0
Acambis
Address [1] 727 0
Country [1] 727 0
United Kingdom

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35922 0
Address 35922 0
Country 35922 0
Phone 35922 0
Fax 35922 0
Email 35922 0
Contact person for public queries
Name 9876 0
N/A
Address 9876 0
(There is no appropriate contact person for this study - individual study sites will use their own healthy volunteer databases/private practises together with local advertising measures to meet recruitment targets for the study)
Country 9876 0
Phone 9876 0
N/A
Fax 9876 0
Email 9876 0
N/A
Contact person for scientific queries
Name 804 0
Matt Dobson
Address 804 0
Acambis Research Limited
Peterhouse Technology Park
100 Fulbourn Rd
Cambridge CB1 9PT
Country 804 0
United Kingdom
Phone 804 0
+44 (0)1223275300
Fax 804 0
Email 804 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.