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287615 containing HBsAg with adjuvants

Phase 1

Hepatitis B Disease | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jul 30, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

287615 containing HBsAg with adjuvants · 1 trial · 1 indication

Phase 1 1
NCT00508833Safety and Efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' Candidate Adjuvanted Vaccines (287615)Hepatitis B Disease
COMPLETED200 Analytics
PHASE1COMPLETED
Safety and Efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' Candidate Adjuvanted Vaccines (287615)
Hepatitis B DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Intensity of the CTL response at Week 6

Secondary Endpoints

Solicited symptoms (7 days), other AEs (up to 6 mths), SAEs (entire study), intensity of CTL response at Week 46, 48, 78; anti-HBs response up to week 78
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
287615 containing HBsAg with adjuvantsBIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 l...

Countries:Belgium
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Frequently asked questions about 287615 containing HBsAg with adjuvants

What is 287615 used for?

287615 is an investigational vaccine being studied for the prevention of Hepatitis B Disease. It is a candidate adjuvanted vaccine developed by GSK plc. The vaccine is currently in Phase 1 clinical development, meaning it is still being tested in clinical trials and is not yet approved for public use.

Who makes 287615?

287615 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company conducted a Phase 1 clinical trial to evaluate the safety and efficacy of this candidate adjuvanted vaccine for Hepatitis B Disease.

What phase is 287615 in?

287615 is in Phase 1 clinical development. It is an investigational vaccine for Hepatitis B Disease and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine remains in early-stage clinical testing.

What clinical trials is 287615 in?

287615 has been studied in one completed Phase 1 clinical trial with the identifier NCT00508833. This trial, titled 'Safety and Efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' Candidate Adjuvanted Vaccines (287615)', enrolled 200 participants in Belgium to evaluate the vaccine's safety and efficacy for Hepatitis B Disease.

Is 287615 a monoclonal antibody?

No, 287615 is not a monoclonal antibody. It is a vaccine that contains HBsAg with adjuvants, designed to elicit an immune response against Hepatitis B. The vaccine is being developed by GSK plc and is currently in Phase 1 clinical trials for the prevention of Hepatitis B Disease.