Recent Updates
Recently added Catalysts

287615 containing HBsAg with adjuvants

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00508833Safety and Efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' Candidate Adjuvanted Vaccines (287615)PHASE1 COMPLETED 200 — — Mar 1, 2000 -Jul 30, 20071 Belgium
Unlock Drug Trial Details
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
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
287615 containing HBsAg with adjuvantsBIOLOGICAL -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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
Unlock Eligibility Criteria