Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000681651
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
Long Term Immunogenicity of the JE Vaccine IC51
Scientific title
Long Term Immunogenicity 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 829 0
Condition category
Condition code
Neurological 896 896 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 Phase III follow-up study to assess long term safety 6 months after the first vacccination with IC51 and to assess in a subgroup the long term immunogenicity up to 24 months
Intervention code [1] 719 0
None
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1161 0
The primary objective is to assess the immunogenicity of the JE vaccine IC51 in subjects
Timepoint [1] 1161 0
24 months after the first vaccination
Secondary outcome [1] 2126 0
To investigate the safety 6 months after the first vaccination and the frequency of vaccination-related adverse events during the study period.
Timepoint [1] 2126 0

Eligibility
Key inclusion criteria
Healthy subjects. 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
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
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] 987 0
Commercial sector/Industry
Name [1] 987 0
Intercell AG
Country [1] 987 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Intercell AG
Address
Country
Austria
Secondary sponsor category [1] 851 0
Commercial sector/Industry
Name [1] 851 0
Intercell AG
Address [1] 851 0
Country [1] 851 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36220 0
Address 36220 0
Country 36220 0
Phone 36220 0
Fax 36220 0
Email 36220 0
Contact person for public queries
Name 9908 0
Professor John McBride
Address 9908 0
Cairns Base Hospital
Level 4 Block B,
The Esplanade
Cairns QLD 4870
Country 9908 0
Australia
Phone 9908 0
+61 7 40508085
Fax 9908 0
Email 9908 0
N/A
Contact person for scientific queries
Name 836 0
Professor John McBride
Address 836 0
Cairns Base Hospital
Level 4 Block B
The Esplanade
Cairns QLD 4870
Country 836 0
Australia
Phone 836 0
+61 7 40508085
Fax 836 0
Email 836 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.