Last updated: 11/04/2018 00:33:05
Immunogenicity & reactogenicity of various formulations of recombinant hepatitis B vaccine with different adjuvants
GSK study ID
208129/005
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 and reactogenicity of various formulations of GSK Biologicals’ (previously SmithKline Beecham Biologicals') recombinant hepatitis B vaccine with different adjuvants in healthy adult volunteers
Trial description: The purpose of this study is to evaluate the immunogenicity and reactogenicity of various formulations of recombinant hepatitis B vaccine with different adjuvants in healthy adult volunteers following the 0, 1, 6 months schedule
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Occurrence and intensity of solicited local and general symptoms
Timeframe: 8 days follow-up after vaccination
Secondary outcomes:
Anti-HBs antibody concentrations
Timeframe: Months 0, 1, 3, 6, 7, 8 and 12
Occurrence, intensity of unsolicited adverse events
Timeframe: 30-day follow-up after vaccination
Occurrence of serious adverse events
Timeframe: During the study period up to 30 days after last vaccination
Interventions:
Biological/vaccine: Engerix™-B
Biological/vaccine: HBV-MPL vaccine (208129)
Biological/vaccine: Hepatitis B vaccine, experimental formulation
Enrollment:
60
Observational study model:
Not applicable
Primary completion date:
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 1993 to July 1994
Type
Interventional
Phase
2
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.
- Serological signs of HBV infection
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.
- Serological signs of HBV infection
- Elevated serum liver enzymes
- Any vaccination against hepatitis B in the past.
- Any previous administration of MPL.
- 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
Not applicable
Actual study completion date
1994-31-07
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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