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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00197184
Registration number
NCT00197184
Ethics application status
Date submitted
15/09/2005
Date registered
20/09/2005
Titles & IDs
Public title
Long Term Follow-up Study at Years 2, 3, 4 and 5 Where 2 Dosing Schedules of the Combined Hepatitis A and B Vaccine Were Compared
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Scientific title
Evaluate the Persistence of Immune Response of GSK Biologicals' Twinrix™ Vaccine, Administered According to a 0,6 Month Schedule and a 0,1,6 Month Schedule, in Healthy Children Aged Between 1-11 Years at the Time of First Vaccine Dose
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Secondary ID [1]
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208127/133 (EXT Y3)
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Secondary ID [2]
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208127/132 (EXT Y2)
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis B
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Hepatitis A
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Twinrix™ Adult
Treatment: Other - Twinrix™ Junior
Experimental: Twinrix Junior - Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
Active comparator: Twinrix Adult - Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
Treatment: Other: Twinrix™ Adult
Intramuscular injection in the left deltoid, 2 doses, Adult formulation in primary study.
Treatment: Other: Twinrix™ Junior
Intramuscular injection in the left deltoid, 3 doses, junior formulation in primary study.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Anti-hepatitis A (HAV) Antibody Concentrations
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Assessment method [1]
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Geometric mean concentration for anti-HAV antibodies expressed as Milli-International Units per milliliter (mIU/mL)
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Timepoint [1]
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Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)
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Primary outcome [2]
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Anti-hepatitis B (HBs) Antibody Concentrations
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Assessment method [2]
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Geometric mean concentration for anti-HBs antibodies expressed as Milli-International Units per milliliter (mIU/mL).
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Timepoint [2]
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Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)
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Primary outcome [3]
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Anti-HAV Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.
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Assessment method [3]
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Any subjects becoming seronegative for anti-HAV antibodies (i.e. titres \< 15 mIU/ml) at any long term time point, were to receive an additional vaccine dose administered between 6 to 12 months after Year 5 time point.
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Timepoint [3]
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Before and one month after additional vaccination
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Primary outcome [4]
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Anti-HBs Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.
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Assessment method [4]
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Subjects losing seroprotective anti-HBs antibody titres (i.e. titres \< 10 mIU/ml) at any long term time point, received an Engerix challenge dose. The table presents the geometric mean concentrations for anti-HBs antibodies, expressed as Milli-International Units per milliliter (mIU/mL).
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Timepoint [4]
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Before and One month after additional vaccination
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Secondary outcome [1]
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Number of Subjects Reporting Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy.
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Assessment method [1]
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A serious adverse event (SAE) is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
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Timepoint [1]
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From last study visit of the primary study up to Year 5 long term follow-up
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Secondary outcome [2]
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Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited Local Symptoms
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Assessment method [2]
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Solicited local symptoms assessed include pain, redness and swelling at the vaccine injection site.
Any= regardless of intensity grade; Grade 3 Pain= spontaneously painful
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Timepoint [2]
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during the 4-day follow-up period after additional vaccination
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Secondary outcome [3]
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Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited General Symptoms.
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Assessment method [3]
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Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.
Any= regardless of intensity grade or relationship to vaccination; grade 3= prevented normal activity; Related= considered by the investigator to be causally related to the vaccination
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Timepoint [3]
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During the 4-day follow-up period after additional vaccination
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Secondary outcome [4]
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Number of Subjects Receiving an Additional Vaccine Dose and Reporting Unsolicited Adverse Events (AEs).
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Assessment method [4]
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An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Timepoint [4]
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During the 30-day follow-up period after additional vaccination.
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Secondary outcome [5]
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Number of Subjects Receiving an Additional Vaccine Dose and Reporting Any Serious Adverse Events
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Assessment method [5]
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A serious adverse event (SAE) is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
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Timepoint [5]
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At least one month after additional vaccination
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Eligibility
Key inclusion criteria
* Participation in primary study
* Written informed consent obtained before each long term follow up visit.
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Minimum age
3
Years
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Maximum age
13
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
10/03/2004
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Sample size
Target
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Accrual to date
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Final
276
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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GSK Investigational Site - North Adelaide
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Recruitment hospital [2]
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GSK Investigational Site - Carlton
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Recruitment postcode(s) [1]
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5006 - North Adelaide
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Recruitment postcode(s) [2]
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3053 - Carlton
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Bruxelles
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Country [2]
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Spain
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State/province [2]
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Barcelona
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Country [3]
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Spain
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State/province [3]
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Blanes (Girona)
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Country [4]
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Spain
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State/province [4]
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Cerdanyola Del Vallés / Barcelona
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Country [5]
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Spain
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State/province [5]
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Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of the study vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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Trial website
https://clinicaltrials.gov/study/NCT00197184
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Trial related presentations / publications
Marshall H, Nolan T, Diez Domingo J, Rombo L, Sokal EM, Mares J, Casanovas JM, Kuriyakose S, Leyssen M, Jacquet JM. Long-term (5-year) antibody persistence following two- and three-dose regimens of a combined hepatitis A and B vaccine in children aged 1-11 years. Vaccine. 2010 Jun 17;28(27):4411-5. doi: 10.1016/j.vaccine.2010.04.040. Epub 2010 Apr 29.
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00197184