Last updated: 11/04/2018 00:36:25
Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years
GSK study ID
208129/047
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A phase III, clinical trial comparing the persistence of GSK Biologicals new adjuvanted hepatitis B vaccine to a double dose of Engerix™-B at months 24, 30, 36, in pre-haemodialysis/haemodialysis patients (≥15 years of age)
Trial description: Persistence of anti-HBs antibodies at Month 24, 30 and 36 in subjects who had completed primary vaccination was evaluated. The anamnestic response to a booster dose was evaluated in subjects with anti-HBs antibody titres < 10 mIU/ml at previous timepoint. The study also evaluated the effect of a booster dose of the vaccine (Month 42) after primary vaccination.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Hepatitis B adjuvanted vaccine
Biological/vaccine: Engerix-B
Enrollment:
120
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
SB208129
Collaborators
Not applicable
Study date(s)
March 2002 to January 2004
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
15+ years
Accepts healthy volunteers
No
- Subjects were to have completed primary vaccination course.
- A male or female > = 15 years of age at the time of the first vaccination.
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- Pregnant or lactating female.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects were to have completed primary vaccination course. A male or female > = 15 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject/ from the parents or guardians of the subject.
- If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she was to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.
Exclusion criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- Pregnant or lactating female.
Trial location(s)
Location
GSK Investigational Site
Bandar Tun Razak, Cheras, Malaysia, 56000
Status
Study Complete
Location
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2004-08-01
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
Additional information
Not applicable
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