Last updated: 11/04/2018 00:33:14
Evaluation of immunogenicity and reactogenicity of various formulations of recombinant hepatitis B vaccine
GSK study ID
208129/006
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 in healthy adult volunteers
Trial description: The purpose of the present trial is to evaluate 6 vaccine formulations of recombinant hepatitis B vaccine for their reactogenicity and immunogenicity when administered at 0-2 months with a booster at month 12
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Anti-HBs antibody concentrations
Timeframe: After two doses and after the booster dose
Secondary outcomes:
Occurrence and intensity of local and general solicited symptoms
Timeframe: 8 days after vaccination
Anti-HBs antibody concentrations
Timeframe: Screening, M1, 2, 3, 4, 6, 12, 13
Occurrence of unsolicited adverse events
Timeframe: 30-day after vaccination
Occurrence of serious adverse events
Timeframe: During the study period and 30 days after the last vaccination
Interventions:
Biological/vaccine: HBsAg formulated with different concentrations of MPL and Aluminium Salts
Biological/vaccine: Engerix™-B
Enrollment:
321
Observational study model:
Not applicable
Primary completion date:
1995-30-04
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
Hepatitis B Vaccine, Recombinant
Collaborators
Not applicable
Study date(s)
November 1993 to April 1995
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.
- Positivity for anti hepatitis antibodies.
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.
- Positivity for anti hepatitis antibodies.
- 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.
- 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
1995-30-04
Actual study completion date
1995-30-04
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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