Last updated: 11/04/2018 00:34:44
Immunogenicity and safety of GSK Biologicals' HBV-MPL vaccine (2 doses), and of Engerix™-B (3 doses) in healthy adults
GSK study ID
208129/030
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 safety of GSK Biologicals’ novel adjuvanted hepatitis B vaccine administered according to a 0, 6 month schedule and of Engerix™-B administered according to a 0, 1, 6 month schedule in healthy adults
Trial description: This study is undertaken to assess the immune response and safety profile of 4 lots of the novel adjuvanted hepatitis B vaccine that were formulated following different processes, with Engerix™-B as the control vaccine
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Anti-HBs antibody concentrations
Timeframe: At month 7
Secondary outcomes:
Anti-HBs antibody concentrations
Timeframe: At months 1, 2 and 6
Occurrence and intensity of solicited local and general symptoms
Timeframe: 4-day follow-up period after each vaccination
Occurrence, intensity and relationship to vaccination of unsolicited symptoms
Timeframe: 30-day follow-up period after each vaccination
Occurrence, intensity and relationship to vaccination of SAEs
Timeframe: Throughout the entire study
Interventions:
Biological/vaccine: Engerix™-B
Biological/vaccine: HBV-MPL vaccine 208129
Enrollment:
200
Observational study model:
Not applicable
Primary completion date:
1999-31-07
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
Hepatitis B Vaccine, Recombinant
Collaborators
Not applicable
Study date(s)
December 1998 to July 1999
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
15 - 50 Years
Accepts healthy volunteers
Yes
- A male or female between 15 and 50 years of age at the time of the first vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
- Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female between 15 and 50 years of age at the time of the first vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the subject and/or from the parents or guardians of the subject.
- If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to vaccination and up to two months after the last vaccination
Exclusion criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
- Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
- Previous vaccination against hepatitis B.
- History of significant and persisting hematological, hepatic, renal, cardiac or respiratory disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at the time of enrollment.
- Hepatomegaly, right upper quadrant abdominal pain or tenderness.
- Oral temperature of ≥37.5°C (99.5°F).
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period.
- Pregnant or lactating female.
- History of chronic alcohol consumption and/or intravenous drug abuse
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
1999-31-07
Actual study completion date
1999-31-07
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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