Last updated: 11/04/2018 01:35:41
Safety and efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' candidate adjuvanted vaccines (287615)
GSK study ID
287615/005
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Safety and the efficacy of GSK Biologicals' candidate adjuvanted vaccines (287615) containing HBsAg with various adjuvants to induce cytotoxic T lymphocytes (CTL) in healthy adult volunteers
Trial description: This study was done to evaluate the effect of various adjuvants in combination with HBsAg as a model antigen on the induction of immune responses, mainly cytotoxic T lymphocytes (CTL) in healthy volunteers. The study was also done to evaluate the safety and reactogenicity of the various adjuvanted vaccines.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: 287615 containing HBsAg with adjuvants
Enrollment:
200
Observational study model:
Not applicable
Primary completion date:
2002-28-02
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B disease
Product
SB287615
Collaborators
Not applicable
Study date(s)
March 2000 to February 2002
Type
Interventional
Phase
1/2
Participation criteria
Sex
Female & Male
Age
18 - 40 Years
Accepts healthy volunteers
Yes
- Healthy volunteers between 18 and 40 years of age
- Written informed consent obtained from subject
- Any hepatitis B vaccination.
- Positive HBV serological markers: anti-HBs, anti-HBc, and/ or HBsAg
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy volunteers between 18 and 40 years of age
- Written informed consent obtained from subject
- Female of non-childbearing potential
Exclusion criteria:
- Any hepatitis B vaccination.
- Positive HBV serological markers: anti-HBs, anti-HBc, and/ or HBsAg
- Pregnancy or lactating female
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days or 7 half-lives (whichever is the longer) preceding the first vaccine administration
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
2002-28-02
Actual study completion date
2002-28-02
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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