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DTPw-HBV/Hib Kft vaccine GSK323527A

Phase 3

Hepatitis B | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Sep 28, 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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment148
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00332566Assess Immunogenicity, Reactogenicity, Safety of a Booster of GSK Biologicals DTPw-HBV/Hib Kft Compared to DTPw-HBV/HibPHASE3 COMPLETED 148Jun 1, 2006Oct 1, 2006Sep 28, 20162 Argentina, Nicaragua
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Study Endpoints
Primary Endpoints
Anti-polyribosyl-ribitol-phosphate (PRP) antibody concentration
One month after the booster dose
Anti-hepatitis B surface antigen (HBs) antibody concentration
One month after the booster dose
Anti-diphtheria antibody concentration
One month after the booster dose
Anti-tetanus antibody concentration
One month after the booster dose
Secondary Endpoints
Anti-Bordetella pertussis (BPT) antibody concentration
One month after the booster dose
Anti-PRP antibody concentration
Prior to the booster dose
Anti-HBs antibody concentration
Prior to the booster dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group AEXPERIMENTAL -
Group BACTIVE_COMPARATOR -
Interventions
NameTypeDescription
DTPw-HBV/Hib Kft vaccine GSK323527ABIOLOGICALIntramuscular injection, 1 dose
Tritanrix™-HepB/Hiberix™BIOLOGICALIntramuscular injection, 1 dose
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Eligibility Criteria
Age Range18 Months — 24 Months
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female toddler, 18 to 24 months of age at the time of booster vaccination, who completed the three-dose pr...

Countries:ArgentinaNicaragua
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