Last updated: 11/04/2018 00:34:36
Safety and immunogenicity of GSK Bio's candidate HBV-MPL vaccines compared to Engerix™-B, in healthy adolescents
GSK study ID
208129/028
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Study to assess the feasibility of GSK Bio's candidate HBV / MPL vaccines following different schedules and formulations and to compare their safety and immunogenicity to that of Engerix™-B in healthy adolescents aged 11 to 15
Trial description: In this study the safety and immunogenicity of 2 different formulations of the candidate HBV-MPL vaccine administered according to a 0, 6-month schedule were explored and compared to that of Engerix™-B in healthy adolescents aged 11 to 15
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Occurrence of Serious adverse experiences (SAE)
Timeframe: During the study period
Occurrence, intensity and relationship to vaccination of solicited local and general symptoms
Timeframe: During the 8-day follow-up period after vaccination
Occurrence, intensity and causal relationship of unsolicited adverse events
Timeframe: 31-day follow-up period after vaccination
Secondary outcomes:
Anti-HBs antibody concentrations
Timeframe: At months 1, 2, 6, and 7
Cell mediated immunity
Timeframe: At months 1, 6, and 7
Interventions:
Biological/vaccine: HBV-MPL vaccine Formulation A
Biological/vaccine: HBV-MPL vaccine Formulation B
Biological/vaccine: Engerix™-B
Enrollment:
200
Observational study model:
Not applicable
Primary completion date:
1999-31-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
Hepatitis B Vaccine, Recombinant
Collaborators
Not applicable
Study date(s)
March 1998 to May 1999
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
11 - 15 Years
Accepts healthy volunteers
Yes
- Age: between 11 and 15 years 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:
- Age: between 11 and 15 years 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 parents or guardians of the subject and from the subject himself/herself in all subjects 15 years of age.
- If the subject is female, she must be of non-childbearing potential, if of childbearing potential, she must be abstinent or have used an adequate contraceptive for one month prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series
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 of a vaccine not foreseen by the study protocol during the period starting from one week before each dose of vaccine and ending 30 days after.
- Previous vaccination against hepatitis B virus.
- Previous vaccination with vaccine containing MPL.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- 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.
- Axillary temperature of ≥ 37.5° C.
- Administration of immunoglobulin and / or any blood product within the six months preceding the first dose of study vaccine or planned administration during the study period.
- Pregnant or lactating female.
- History of chronic disease deemed by the investigator to be relevant.
- Positive for anti-HBV antibodies at screening
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
1999-31-05
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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