Last updated: 11/04/2018 00:36:16
Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years
GSK study ID
208129/042
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: To compare the immunogenicity & safety of GSK Biologicals new adjuvanted hepatitis B vaccine to a double dose of Engerix™-B, in pre-haemodialysis/haemodialysis patients (≥15 years of age)
Trial description: Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Vaccine: Hepatitis B adjuvanted vaccine
Vaccine: Engerix-B
Enrollment:
141
Observational study model:
Not applicable
Primary completion date:
2001-16-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
Hepatitis B Vaccine, Recombinant
Collaborators
Not applicable
Study date(s)
February 2001 to March 2001
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
15+ years
Accepts healthy volunteers
No
- 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.
- Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
- Previous vaccination against hepatitis B.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
- Seronegative for anti-HBs antibodies, anti-HBc antibodies & Hepatitis B Surface antigen (HBsAg).
- If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.
- Pre-haemodialysis patient* or a patient on haemodialysis.
Exclusion criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
- Previous vaccination against hepatitis B.
- History of hepatitis B infection.
- Known exposure to hepatitis B virus within 6 weeks. Pregnant or lactating female
- Clinically abnormal ALT/AST values (> 3 times normal values)
Trial location(s)
Location
GSK Clinical Trials Call Center
Hradec, Králové, Czech Republic
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
2001-16-03
Actual study completion date
2001-16-03
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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