Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00197184
Registration number
NCT00197184
Ethics application status
Date submitted
15/09/2005
Date registered
20/09/2005
Date last updated
20/08/2018
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
Query!
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
Query!
Secondary ID [1]
0
0
208127/133 (EXT Y3)
Query!
Secondary ID [2]
0
0
208127/132 (EXT Y2)
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hepatitis B
0
0
Query!
Hepatitis A
0
0
Query!
Condition category
Condition code
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Other interventions - Twinrix™ Adult
Other interventions - 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).
Other interventions: Twinrix™ Adult
Intramuscular injection in the left deltoid, 2 doses, Adult formulation in primary study.
Other interventions: Twinrix™ Junior
Intramuscular injection in the left deltoid, 3 doses, junior formulation in primary study.
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Anti-hepatitis A (HAV) Antibody Concentrations
Query!
Assessment method [1]
0
0
Geometric mean concentration for anti-HAV antibodies expressed as Milli-International Units per milliliter (mIU/mL)
Query!
Timepoint [1]
0
0
Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)
Query!
Primary outcome [2]
0
0
Anti-hepatitis B (HBs) Antibody Concentrations
Query!
Assessment method [2]
0
0
Geometric mean concentration for anti-HBs antibodies expressed as Milli-International Units per milliliter (mIU/mL).
Query!
Timepoint [2]
0
0
Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)
Query!
Primary outcome [3]
0
0
Anti-HAV Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Before and one month after additional vaccination
Query!
Primary outcome [4]
0
0
Anti-HBs Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.
Query!
Assessment method [4]
0
0
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).
Query!
Timepoint [4]
0
0
Before and One month after additional vaccination
Query!
Secondary outcome [1]
0
0
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.
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
From last study visit of the primary study up to Year 5 long term follow-up
Query!
Secondary outcome [2]
0
0
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited Local Symptoms
Query!
Assessment method [2]
0
0
Solicited local symptoms assessed include pain, redness and swelling at the vaccine injection site.
Any= regardless of intensity grade; Grade 3 Pain= spontaneously painful
Query!
Timepoint [2]
0
0
during the 4-day follow-up period after additional vaccination
Query!
Secondary outcome [3]
0
0
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited General Symptoms.
Query!
Assessment method [3]
0
0
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
Query!
Timepoint [3]
0
0
During the 4-day follow-up period after additional vaccination
Query!
Secondary outcome [4]
0
0
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Unsolicited Adverse Events (AEs).
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
During the 30-day follow-up period after additional vaccination.
Query!
Secondary outcome [5]
0
0
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Any Serious Adverse Events
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
At least one month after additional vaccination
Query!
Eligibility
Key inclusion criteria
- Participation in primary study
- Written informed consent obtained before each long term follow up visit.
Query!
Minimum age
3
Years
Query!
Query!
Maximum age
13
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/11/2003
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
10/03/2004
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
276
Query!
Recruitment in Australia
Recruitment state(s)
SA,VIC
Query!
Recruitment hospital [1]
0
0
GSK Investigational Site - North Adelaide
Query!
Recruitment hospital [2]
0
0
GSK Investigational Site - Carlton
Query!
Recruitment postcode(s) [1]
0
0
5006 - North Adelaide
Query!
Recruitment postcode(s) [2]
0
0
3053 - Carlton
Query!
Recruitment outside Australia
Country [1]
0
0
Belgium
Query!
State/province [1]
0
0
Bruxelles
Query!
Country [2]
0
0
Spain
Query!
State/province [2]
0
0
Barcelona
Query!
Country [3]
0
0
Spain
Query!
State/province [3]
0
0
Blanes (Girona)
Query!
Country [4]
0
0
Spain
Query!
State/province [4]
0
0
Cerdanyola Del Vallés / Barcelona
Query!
Country [5]
0
0
Spain
Query!
State/province [5]
0
0
Valencia
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
GlaxoSmithKline
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00197184
Query!
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
GSK Clinical Trials
Query!
Address
0
0
GlaxoSmithKline
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00197184
Download to PDF