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
Study complete
Study complete
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:
Enrollment:
200
Primary completion date:
1999-31-05
Observational study model:
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)
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
Study complete
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website