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HBV-MPL vaccine

Phase 3

Hepatitis B | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jun 17, 2008

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials3
Total Enrollment703
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00696891Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in AdultsPHASE3 COMPLETED 380Jun 1, 1997 -Jun 13, 20083 Belgium, Canada +1
NCT00698906Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 19-40 yPHASE2 COMPLETED 160Jun 1, 1997 -Jun 17, 20081 Austria
NCT00698555Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 18-40 yPHASE2 COMPLETED 163Mar 1, 1997 -Jun 17, 20081 Belgium
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Study Endpoints
Primary Endpoints
Anti-HBs antibody concentrations
At Month 7
Secondary Endpoints
Anti-HBs antibody concentrations
At Months 1, 2, 6, 7 and 12
Occurrence and intensity of solicited local symptoms
4-day follow-up after vaccination
Occurrence and intensity and relationship to vaccination of solicited general symptoms
4-day follow-up after vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group AEXPERIMENTAL -
Group BACTIVE_COMPARATOR -
Group CEXPERIMENTAL -
Group DEXPERIMENTAL -
Group EEXPERIMENTAL -
Group FACTIVE_COMPARATOR -
Interventions
NameTypeDescription
HBV-MPL vaccineBIOLOGICAL3-dose intramuscular injection
Engerix™-BBIOLOGICAL3-dose intramuscular injection
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Eligibility Criteria
Age Range50 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Age: 50 to 70 years old. * Good physical condition as established by clinical examination and history taking at the time of entry. * Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period. * Written info...

Countries:BelgiumCanadaSwedenAustria
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