Last updated: 11/06/2018 23:18:47
Long term F/U studies at Y5&6 to demonstrate the equivalence of 2 vaccination schedules of combined hepatitis A & B vaccine
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Evaluate the persistence of immune response of GSK Biologicals’ TWINRIX™ ADULT, administered according to 0,6 month schedule and 0,12 month schedule, in volunteers aged 12-15 years inclusive at the time of first vaccine dose
Trial description: To evaluate the persistence of immune response 5 years and 6 years after the first vaccine dose.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Combined Hepatitis A and B vaccine
Enrollment:
143
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Burgess MA et al. (2010) Antibody persistence six years after two doses of combined hepatitis A and B vaccine. Vaccine 28(10):2222-2226.
Medical condition
Hepatitis B
Product
SB208127
Collaborators
Not applicable
Study date(s)
September 2003 to December 2003
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12 - 15 years
Accepts healthy volunteers
Yes
- Inclusion Criteria:
- Subjects who received GSK Biologicals' combined hepatitis A and B vaccine in the primary study (HAB-082). Subjects were aged 12 to 15 years at the time of the first vaccination.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria:
- Subjects who received GSK Biologicals' combined hepatitis A and B vaccine in the primary study (HAB-082). Subjects were aged 12 to 15 years at the time of the first vaccination.
Trial location(s)
Location
GSK Investigational Site
Paramatta, New South Wales, Australia, 2124
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
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2003-17-12
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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Additional information
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