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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
208127/133 (EXT Y3)
Secondary ID [2] 0 0
208127/132 (EXT Y2)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B 0 0
Hepatitis A 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Anti-hepatitis A (HAV) Antibody Concentrations - Geometric mean concentration for anti-HAV antibodies expressed as Milli-International Units per milliliter (mIU/mL)
Timepoint [1] 0 0
Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)
Primary outcome [2] 0 0
Anti-hepatitis B (HBs) Antibody Concentrations - Geometric mean concentration for anti-HBs antibodies expressed as Milli-International Units per milliliter (mIU/mL).
Timepoint [2] 0 0
Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)
Primary outcome [3] 0 0
Anti-HAV Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose. - 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.
Timepoint [3] 0 0
Before and one month after additional vaccination
Primary outcome [4] 0 0
Anti-HBs Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose. - 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).
Timepoint [4] 0 0
Before and One month after additional vaccination
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. - 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.
Timepoint [1] 0 0
From last study visit of the primary study up to Year 5 long term follow-up
Secondary outcome [2] 0 0
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited Local Symptoms - Solicited local symptoms assessed include pain, redness and swelling at the vaccine injection site.
Any= regardless of intensity grade; Grade 3 Pain= spontaneously painful
Timepoint [2] 0 0
during the 4-day follow-up period after additional vaccination
Secondary outcome [3] 0 0
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited General Symptoms. - 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
Timepoint [3] 0 0
During the 4-day follow-up period after additional vaccination
Secondary outcome [4] 0 0
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Unsolicited Adverse Events (AEs). - 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.
Timepoint [4] 0 0
During the 30-day follow-up period after additional vaccination.
Secondary outcome [5] 0 0
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Any Serious Adverse Events - 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.
Timepoint [5] 0 0
At least one month after additional vaccination

Eligibility
Key inclusion criteria
- Participation in primary study

- Written informed consent obtained before each long term follow up visit.
Minimum age
3 Years
Maximum age
13 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - North Adelaide
Recruitment hospital [2] 0 0
GSK Investigational Site - Carlton
Recruitment postcode(s) [1] 0 0
5006 - North Adelaide
Recruitment postcode(s) [2] 0 0
3053 - Carlton
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bruxelles
Country [2] 0 0
Spain
State/province [2] 0 0
Barcelona
Country [3] 0 0
Spain
State/province [3] 0 0
Blanes (Girona)
Country [4] 0 0
Spain
State/province [4] 0 0
Cerdanyola Del Vallés / Barcelona
Country [5] 0 0
Spain
State/province [5] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00197184
Trial related presentations / publications
Marshall H, Nolan T, Díez Domingo J, Rombo L, Sokal EM, Marès 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.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications