Last updated: 11/04/2018 00:32:43
Evaluation of immunogenicity, reactogenicity and safety of HBV-MPL vaccine vs Engerix™-B, in haemodialysis patients
GSK study ID
208129/002
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Study to evaluate the immunogenicity, reactogenicity and safety of GSK Biologicals' (previously SmithKline Beecham Biologicals') MPL-adjuvanted recombinant hepatitis B vaccine versus Engerix™-B, in haemodialysis patients
Trial description: This trial is designed to evaluate the immunogenicity, reactogenicity and safety of an MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in haemodialysis patients with or without previous vaccination against hepatitis B
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Occurrence and intensity of solicited local and general symptoms
Timeframe: 4-day follow-up period after each vaccination
Occurrence of unsolicited adverse events
Timeframe: During the course of the study
Occurrence of serious adverse events
Timeframe: During the course of the study
Anti-HBs antibody concentrations
Timeframe: Pre, Day 0, Day 30, Day 60, Day 90, Day 120, D180, D210 depending on group allocation
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: HBV-MPL vaccine 208129
Biological/vaccine: Engerix™-B
Enrollment:
30
Observational study model:
Not applicable
Primary completion date:
1992-31-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
Hepatitis B Vaccine, Recombinant
Collaborators
Not applicable
Study date(s)
February 1992 to December 1992
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Dialysis patients
- A medical examination including physical examination and medical history as well as serological screening established acceptability for enrollment into the study.
- History of persistent hepatic, cardiac or respiratory disease
- Any acute disease at the moment of entry into the study
Inclusion and exclusion criteria
Inclusion criteria:
- Dialysis patients
- A medical examination including physical examination and medical history as well as serological screening established acceptability for enrollment into the study.
- Age: from 18 years onwards
- Seronegative for anti- hepatitis antibodies
Exclusion criteria:
- History of persistent hepatic, cardiac or respiratory disease
- Any acute disease at the moment of entry into the study
- Chronic alcohol consumption
- Hepatomegaly, right upper quadrant pain or tenderness
- Any treatment with coticosteroids or immunomodulating drugs
- Known hypersensitivity to any component of the vaccine
- Simultaneous participation in any other clinical trial
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
1992-31-12
Actual study completion date
1992-31-12
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
Additional information
Not applicable
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