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Recombinant MPL- adjuvanted hepatitis B vaccine

Phase 3

Hepatitis B | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jun 16, 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 Trials1
Total Enrollment116
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00697931Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-RespondersPHASE3 COMPLETED 116May 1, 1997Jun 1, 1998Jun 16, 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 2, 6, 7 and 12
Occurrence and intensity of solicited local symptoms
4-day follow-up after vaccination
Occurrence, intensity and relationship 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 -
Interventions
NameTypeDescription
Recombinant MPL- adjuvanted hepatitis B vaccineBIOLOGICALIntramuscular injection, 3 doses
Engerix™-BBIOLOGICALIntramuscular injection, 3 doses
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Age: older than 18 years of age. * Documented non-responders 2 to 5 months after having received 4 doses of a hepatitis B vaccine * Good physical condition as established by clinical examination and history taking at the time of entry. * Female participants who are at risk to ...

Countries:Belgium
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