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Infanrix-Hexa

Phase 3

Hepatitis B | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Sep 16, 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 Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00366366To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV VaccinesPHASE3 COMPLETED 150Sep 1, 2001Sep 1, 2002Sep 16, 2016 -
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Study Endpoints
Primary Endpoints
Anti-HBs conc >=10 mIU/ml, 1 month after the last vaccine dose
Secondary Endpoints
Ab conc/titers against all vaccine antigens
Safety: Solicited symptoms, unsolicited AEs and SAEs
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
Infanrix-HexaBIOLOGICAL -
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Eligibility Criteria
Age Range11 Weeks — 17 Weeks
SexALL
Healthy VolunteersYes

Inclusion Criteria: * A male or female infant at the age of 11 - 17 weeks. * Written informed consent obtained from the parents or guardians of the subject. * Free of obvious health problems as established by clinical examination before entering into the study. * Hepatitis B vaccine at birth and on...

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