Recent Updates
Recently added Catalysts

MPL-Adjuvanted recombinant 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
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00698087Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-BPHASE3 COMPLETED 60Jan 1, 1995Feb 1, 1996Jun 16, 20081 Austria
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Anti-HBs antibody concentrations
At M3 and M13
Occurrence of local and general solicited symptoms
4-day follow-up after vaccination
Occurrence of unsolicited symptoms
30-day follow-up after vaccination
Secondary Endpoints
SAEs
Throughout the study up to 30 days after last vaccination
Anti-HBs antibody concentrations
Months 2, 3, 6, 9, 12, 13
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group AEXPERIMENTAL -
Group BACTIVE_COMPARATOR -
Group CEXPERIMENTAL -
Interventions
NameTypeDescription
MPL-Adjuvanted recombinant hepatitis B vaccineBIOLOGICALIntramuscular injection, 2 or 3 doses, 2 different formulations
Engerix™-BBIOLOGICALIntramuscular injection, 2 or 3 doses
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Between 18 and 40 years old. * Written informed consent will have been obtained from the subjects. * Good physical condition as established by physical examination and history taking at the time of entry. * Female participants will avoid becoming pregnant during the study peri...

Countries:Austria
Unlock Eligibility Criteria