Last updated: 11/02/2018 23:09:18
Long-Term Follow-Up Studies at Year 6, 7, 8, 9, 10: 2 Formulations of Combined Hepatitis A/B Vaccine Compared in Subjects Aged 12-15 years
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Evaluate Persistence of Immune Response of GSK Biologicals’ TWINRIX™ Vaccine Administered According to 0,6 Month Schedule Versus TWINRIX™ JUNIOR Administered According to 0,1,6 Month Schedule, in Subjects Aged 12-15 years at Time of First Vaccine Dose
Trial description: To evaluate the persistence of anti-hepatitis A virus (anti-HAV) and anti-hepatitis B surface antigen (anti-HBs) antibodies up to 6, 7, 8, 9 and 10 years after administration of the first dose of the study vaccine.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of subjects with anti-hepatitis A virus (HAV) antibody concentrations above the cut-off value
Timeframe: Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value
Timeframe: Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination
Serious adverse events (SAE) causally related to primary vaccination or related to hepatitis A or B infection or related to study participation (blood sampling)
Timeframe: From Year 6 through to Year 10
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
244
Primary completion date:
2004-26-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Beran J et al. (2010) Comparison of long-term (10 years) immunogenicity of two- and three-dose regimens of a combined hepatitis A and B vaccine in adolescents. Vaccine. 28(37):5993–5997.
Medical condition
Hepatitis B
Product
SB208127
Collaborators
Not applicable
Study date(s)
May 2004 to June 2004
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12 - 15 years
Accepts healthy volunteers
Yes
- Healthy male and female volunteers vaccinated in study HAB-084.
- Written informed consent obtained from the subject before the blood sampling visit of each year.
- none
Inclusion and exclusion criteria
Inclusion criteria:
- Written informed consent obtained from the subject before the blood sampling visit of each year.
Healthy male and female volunteers vaccinated in study HAB-084.
Exclusion criteria:
none
Trial location(s)
Location
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 03
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2004-26-06
Actual study completion date
2004-26-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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