Last updated: 11/04/2018 00:33:41
Safety, immunogenicity and reactogenicity of recombinant hepatitis B vaccine (adjuvanted & new formulation) and Engerix™-B
GSK study ID
208129/019
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Study to assess the safety, immunogenicity and reactogenicity of GSK Biologicals' (previously SmithKline Beecham Biologicals') adjuvanted recombinant hepatitis B vaccine, recombinant hepatitis B vaccine new formulation and Engerix™-B
Trial description: The purpose of the present trial is to assess the safety, reactogenicity and immunogenicity of adjuvanted hepatitis B vaccine, Engerix™-B and hepatitis B vaccine new formulation when administered at 0, 6 months
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Anti-HBs antibody concentrations
Timeframe: At month 7
Occurrence and intensity of solicited local and general symptoms
Timeframe: 4-day follow-up after vaccination
Occurrence of unsolicited adverse events
Timeframe: 30-days after vaccination
Incidence of serious adverse events
Timeframe: Throughout the study period
Anti-Hbs antibody concentrations
Timeframe: Months 1, 6 and 24
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Engerix™-B
Biological/vaccine: HBV-MPL 208129
Biological/vaccine: Vaccine containing HBsAg absorbed on aluminium salts – experimental formulation
Enrollment:
150
Observational study model:
Not applicable
Primary completion date:
1996-31-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
Hepatitis B Vaccine, Recombinant
Collaborators
Not applicable
Study date(s)
June 1995 to February 1996
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 40 Years
Accepts healthy volunteers
Yes
- Between 18 and 40 years old.
- Written informed consent will have been obtained from the subjects.
- Pregnancy or lactation.
- Positive titres for anti HBs antibody.
Inclusion and exclusion criteria
Inclusion criteria:
- Between 18 and 40 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.
- Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry
Exclusion criteria:
- Pregnancy or lactation.
- Positive titres for anti HBs antibody.
- Any vaccination against hepatitis B in the past.
- Any previous administration of MPL.
- Elevated serum liver enzymes.
- 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.
- Simultaneous administration of any other vaccine(s).
- Administration of 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
1996-31-01
Actual study completion date
1996-29-02
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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