Last updated: 11/04/2018 00:33:58
Study comparing immunogenicity, reactogenicity and safety of GSK Bios' HBV-MPL vaccine with that of Engerix™-B in adults
GSK study ID
208129/022
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Study comparing immunogenicity, reactogenicity and safety of GSK Biologicals' HBV-MPL vaccine with that of Engerix™-B when both are injected according to 3 dose schedule (0, 1, 6 months) in an adult population aged between 50 and 70 years
Trial description: This study is conducted to compare the immunogenicity, reactogenicity and safety of Engerix™-B and HBV-MPL vaccine against hepatitis B infection in an elderly population
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
Anti-HBs antibody concentrations
Timeframe: At Month 7
Secondary outcomes:
Anti-HBs antibody concentrations
Timeframe: At Months 1, 2, 6, 7 and 12
Occurrence and intensity of solicited local symptoms
Timeframe: 4-day follow-up after vaccination
Occurrence and intensity and relationship to vaccination of solicited general symptoms
Timeframe: 4-day follow-up after vaccination
Occurrence and intensity of any symptoms (solicited/ unsolicited).
Timeframe: 4-day follow-up after vaccination
Occurrence, intensity and causal relationship of unsolicited symptoms
Timeframe: Within 30 days after vaccination
Serious adverse events
Timeframe: Throughout study period
Interventions:
Enrollment:
380
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
Hepatitis B Vaccine, Recombinant
Collaborators
Not applicable
Study date(s)
June 1997 to May 1999
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
50 - 70 Years
Accepts healthy volunteers
Yes
- Age: 50 to 70 years old.
- Good physical condition as established by clinical examination and history taking at the time of entry.
- Positive at screening for anti-HBV antibodies.
- Elevated serum liver enzymes
Inclusion and exclusion criteria
Inclusion criteria:
- Age: 50 to 70 years old.
- Good physical condition as established by clinical examination and history taking at the time of entry.
- Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
- Written informed consent obtained from the subjects
Exclusion criteria:
- Positive at screening for anti-HBV antibodies.
- Elevated serum liver enzymes
- History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
- Any acute disease at the moment of entry.
- Chronic alcohol consumption.
- Hepatomegaly, right upper quadrant abdominal pain or tenderness.
- Any chronic drug treatment, including any treatment with immunosuppressive drugs, 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.
- Simultaneous participation in any other clinical trial.
- Previous vaccination with a recombinant hepatitis B vaccine.
- Previous vaccination with an MPL containing vaccine.
- Administration of immunoglobulins in the past 6 months and during the whole study period
- Vaccination one week before and one week after each dose of the study vaccine
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
1999-31-05
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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