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Combined Hepatitis A and B vaccine

Phase 3

Hepatitis B | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Sep 7, 2016

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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment143
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00197171Long Term F/U Studies at Y5&6 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A & B VaccinePHASE3 COMPLETED 143Sep 1, 2003Dec 1, 2003Sep 7, 20162 Australia
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Study Endpoints
Primary Endpoints
Immune persistence in terms of anti-HAV and anti-HBs antibodies and GMCs, 5 and 6 years after administration of first vaccine dose. An additional dose of the study vaccine will be given (between 6 to 12 months after the Year 6 time point) to subjects who
Secondary Endpoints
To record the SAEs that was reported since the last time point.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
Combined Hepatitis A and B vaccineBIOLOGICAL -
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Eligibility Criteria
Age Range12 Years — 15 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Subjects who received GSK Biologicals' combined hepatitis A and B vaccine in the primary study (HAB-082). Subjects were aged 12 to 15 years at the time of the first vaccination.

Countries:Australia
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