Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000396527
Ethics application status
Approved
Date submitted
5/09/2006
Date registered
11/09/2006
Date last updated
11/09/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hepatitis B immunity and response to a booster dose of hepatitis B vaccine in Indigenous children who recieved hepatitis B vaccines in infancy
Scientific title
Hepatitis B immunity and response to a booster dose of hepatitis B vaccine in Indigenous children who recieved hepatitis B vaccines in infancy
Universal Trial Number (UTN)
Trial acronym
Long term hepatitis B immunity
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B immunity in healthy subjects 1362 0
Condition category
Condition code
Inflammatory and Immune System 1455 1455 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adolescents with low immunity will be offered booster doses of the vaccine and have their immunity measured 2-4 weeks post vaccination.
HBVaxII 10microgram dose vaccine will be administered intramsucularly in this study
Study duration is 1 month approximately
Intervention code [1] 1346 0
Prevention
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2007 0
Hepatitis B surface antibody measurement
Timepoint [1] 2007 0
At baseline and 2-4 weeks post vaccination
Secondary outcome [1] 3476 0
Measurement of hepatitis B surface antigen
Timepoint [1] 3476 0
At baseline - prior to vaccination

Eligibility
Key inclusion criteria
Enrolled in the Aboriginal Birth Cohort (ABC).
Minimum age
16 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not enrolled in original Aboriginal Birth Cohort StudyAll participants have their hepatitis B serology measured at baselineBooster vaccination for only those whose HBsAb level <10 IU/ml.

Study design
Purpose of the study
Prevention
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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1592 0
Government body
Name [1] 1592 0
NHMRC
Country [1] 1592 0
Australia
Primary sponsor type
Government body
Name
National Centre for Immunisation Research and Surveillance
Address
Country
Australia
Secondary sponsor category [1] 1398 0
Charities/Societies/Foundations
Name [1] 1398 0
Menzies School of Health research
Address [1] 1398 0
Country [1] 1398 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3016 0
Menzies School of Health Research
Ethics committee address [1] 3016 0
Ethics committee country [1] 3016 0
Australia
Date submitted for ethics approval [1] 3016 0
Approval date [1] 3016 0
02/06/2006
Ethics approval number [1] 3016 0
06/05

Summary
Brief summary
Adolescent enrolled in the Aboriginal Birth Cohort Study will have their serology to hepatitis B measured. Adolescents who received hepatitis B vaccines in infancy and have low immunity will be offered booster doses of the vaccine and have their immunity measured 2-4 weeks post vaccination.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27953 0
Address 27953 0
Country 27953 0
Phone 27953 0
Fax 27953 0
Email 27953 0
Contact person for public queries
Name 10535 0
Nicholas Wood
Address 10535 0
National Centre for Immunisation Research and Surveillance
Locked Bag 4001
The Children's Hospital at Westmead
Westmead NSW 2145
Country 10535 0
Australia
Phone 10535 0
02 9845 1434
Fax 10535 0
02 9845 1418
Email 10535 0
nicholw3@chw.edu.au
Contact person for scientific queries
Name 1463 0
Nicholas Wood
Address 1463 0
National Centre for Immunisation Research and Surveillance
Locked Bag 4001
The Children's Hospital at Westmead
Westmead NSW 2145
Country 1463 0
Australia
Phone 1463 0
02 9845 1434
Fax 1463 0
02 9845 1418
Email 1463 0
nicholw3@chw.edu.au

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.