Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000680662
Ethics application status
Approved
Date submitted
16/10/2005
Date registered
21/10/2005
Date last updated
21/10/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and Tolerability Study of the JE Vaccine IC51
Scientific title
Safety and Tolerability of the Japanese Encephalitis Vaccine IC51(JE-PIV).
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prophylactic Vaccine against Japanese Encephalitis 828 0
Condition category
Condition code
Neurological 895 895 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
A double-blind, randomized controlled Phase III study to investigate the safety and the tolerability of the JE vaccine IC51.The duration of the treatment including a follow-up period is 56 days.
Intervention code [1] 720 0
None
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1159 0
The primary objective is to investigate the safety of IC51 during the vaccination period until 4 weeks after the last vaccination compared with an inactive control
Timepoint [1] 1159 0
Primary outcome [2] 1160 0
The primary objective is to investigate the tolerability of IC51 during the vaccination period until 4 weeks after the last vaccination compared with an inactive control
Timepoint [2] 1160 0
Secondary outcome [1] 2125 0
Rates of serious adverse events and medically attended adverse events in individuals.
Timepoint [1] 2125 0
Before and after immunization with IC51 up to day 56.

Eligibility
Key inclusion criteria
Written informed consent obtained prior to study entry.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine- History of any previous JE vaccination- Immunodeficiency including post-organ-transplantation or immunosuppressive therapy- A family history of congenital or hereditary immunodeficiency- History of autoimmune disease- Any acute infections within 2 weeks prior to enrollment- Known or suspected HIV Infection- Pregnancy, lactation or unreliable contraception in female subjects.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone (IVRS)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation sequence was generated by means of computer software (SAS). Block randomisation was used, stratification is done by IVRS
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 986 0
Commercial sector/Industry
Name [1] 986 0
Intercell AG
Country [1] 986 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Intercell AG
Address
Country
Austria
Secondary sponsor category [1] 850 0
Commercial sector/Industry
Name [1] 850 0
Intercell AG
Address [1] 850 0
Country [1] 850 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36200 0
Address 36200 0
Country 36200 0
Phone 36200 0
Fax 36200 0
Email 36200 0
Contact person for public queries
Name 9909 0
Professor John McBride
Address 9909 0
Cairns Base Hospital
Level 4 Block B
The Esplanade
Cairns QLD 4870
Country 9909 0
Australia
Phone 9909 0
+61 7 40508085
Fax 9909 0
Email 9909 0
N/A
Contact person for scientific queries
Name 837 0
Professor John McBride
Address 837 0
Cairns Base Hospital
Level 4 Block B
The Esplanade
Cairns QLD 4870
Country 837 0
Australia
Phone 837 0
+61 7 40508085
Fax 837 0
Email 837 0
N/A

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.