Last updated: 11/04/2018 00:33:22
Comparison of immuno, reacto and safety of recombinant hepatitis B vaccine with or without MPL in healthy older adults
GSK study ID
208129/009
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Study to compare the immunogenicity, safety and reactogenicity of GSK Biologicals’ (previously SmithKline Beecham Biologicals') recombinant hepatitis B vaccines with and without adjuvant in healthy older adult volunteers
Trial description: In the present study the immunogenicity, reactogenicity and safety of recombinant hepatitis B vaccines with and without MPL will be evaluated in older healthy subjects
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Anti-hepatitis B surface antigen (HBs) antibody concentrations
Timeframe: At M2 and M7
Secondary outcomes:
Anti-pre-S1 antibody concentrations
Timeframe: Screening, Months 1, 2, 3, 6, 7, 8 and 12, depending on group allocation
Anti-HBs antibody concentrations
Timeframe: Screening, Months 1, 2, 3, 6, 7, 8 and 12
Occurrence and intensity of local and general solicited symptoms
Timeframe: 4-day after vaccination
Cell mediated immunity
Timeframe: Month 0, Month 2 and month 7
Occurrence of unsolicited adverse events
Timeframe: 30 days after vaccination
Occurrence of serious adverse events
Timeframe: During the study period and 30 days after last vaccine dose
Interventions:
Biological/vaccine: Engerix™-B
Biological/vaccine: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL
Enrollment:
362
Observational study model:
Not applicable
Primary completion date:
1995-30-11
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
Hepatitis B Vaccine, Recombinant
Collaborators
Not applicable
Study date(s)
January 1994 to December 1995
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
50 - 70 Years
Accepts healthy volunteers
Yes
- Healthy male or female subjects between 50 and 70 years old.
- Written informed consent will have been obtained from the subjects.
- Positive titres for anti hepatitis antibodies
- Any vaccination against hepatitis B in the past.
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy male or female subjects between 50 and 70 years old.
- Written informed consent will have been obtained from the subjects.
- Good physical condition as established by physical examination and history taking at the time of entry
Exclusion criteria:
- Positive titres for anti hepatitis antibodies
- Any vaccination against hepatitis B in the past.
- Any previous administration of MPL
- Elevated serum liver enzymes at two subsequent determinations 14 days apart.
- History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
- Axillary temperature > 37.5°C at the time of injection.
- Any acute disease at the moment of entry.
- Chronic alcohol consumption.
- Any treatment with immunosuppressive or immunostimulant therapy.
- Any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study.
- History of allergic disease likely to be stimulated by any component of the vaccine.
- Administration of any other vaccine(s) or any immunoglobulin during the study period.
- 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
1995-30-11
Actual study completion date
1995-03-12
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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