Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000394549
Ethics application status
Approved
Date submitted
5/09/2006
Date registered
7/09/2006
Date last updated
7/09/2006
Type of registration
Retrospectively registered

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

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B 1360 0
Condition category
Condition code
Inflammatory and Immune System 1452 1452 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hepatitis B serology at baseline
Response to a booster dose of hepatitis B vaccine
HBVaxII 10microgram intramuscularly
Intervention code [1] 1347 0
Prevention
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2004 0
Hepatitis B surface antibody measurement
Timepoint [1] 2004 0
At baseline and 2-4 weeks post vaccination
Secondary outcome [1] 3472 0
Hepatitis B surface antigen
Timepoint [1] 3472 0
Measurement at baseline

Eligibility
Key inclusion criteria
Adolescents born to hepatitis B carrier mothers.
Minimum age
10 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Mother not a hepatitis B carrierAll participants have hepatitis B serology at baselineOnly adolescents with HBsAb <10IU/ml given a booster dose of vaccine.

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
10/12/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1589 0
Government body
Name [1] 1589 0
NHMRC
Country [1] 1589 0
Australia
Primary sponsor type
Government body
Name
National Centre for Immunisation Research and Surveillance
Address
Country
Australia
Secondary sponsor category [1] 1396 0
Government body
Name [1] 1396 0
Sydney South West Area Health Service
Address [1] 1396 0
Country [1] 1396 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3012 0
Sydney South West Area Health Service
Ethics committee address [1] 3012 0
Ethics committee country [1] 3012 0
Australia
Date submitted for ethics approval [1] 3012 0
Approval date [1] 3012 0
06/04/2005
Ethics approval number [1] 3012 0
05-0052
Ethics committee name [2] 3013 0
The Children's Hospital at Westmead
Ethics committee address [2] 3013 0
Ethics committee country [2] 3013 0
Australia
Date submitted for ethics approval [2] 3013 0
Approval date [2] 3013 0
16/09/2005
Ethics approval number [2] 3013 0
2005/071

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

Contacts
Principal investigator
Name 27954 0
Address 27954 0
Country 27954 0
Phone 27954 0
Fax 27954 0
Email 27954 0
Contact person for public queries
Name 10536 0
Nicholas Wood
Address 10536 0
National Centre for Immunisation Research and Surveillance
Locked Bag 4001
The Children's Hospital at Westmead
Westmead NSW 2145
Country 10536 0
Australia
Phone 10536 0
02 9845 1434
Fax 10536 0
Email 10536 0
[email protected]
Contact person for scientific queries
Name 1464 0
Nicholas Wood
Address 1464 0
National Centre for Immunisation Research and Surveillance
Locked Bag 4001
The Children's Hospital at Westmead
Westmead NSW 2145
Country 1464 0
Australia
Phone 1464 0
02 9845 1434
Fax 1464 0
Email 1464 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.