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Hib-MenAC mixed with Tritanrix-HepB

Phase 3

Tetanus | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Oct 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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment800
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00197275Lot-to-lot Consistency of Tritanrix™-HepB/Hib-MenAC & Its Non-inferiority vs Tritanrix™-HepB/Hiberix™ in InfantsPHASE3 COMPLETED 800 — — Feb 1, 2006Nov 1, 2006Oct 7, 20163 Thailand
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Study Endpoints
Primary Endpoints
Immune response 1 month post dose 3 (SBA-MenA/C titers ≥ 1:8, anti-PRP ≥ 0.15 µg/ml, -diphtheria ≥ 0.1 IU/ml (ELISA) OR ≥ 0.016 IU/ml (Vero-cell test), -tetanus ≥ 0.1 IU/ml, -HB concentration ≥ 10 mIU/ml, vaccine response to Bordetella pertus
Secondary Endpoints
Antibody conc or titer, seroprot, seropos and/or vacc response to all antigens administered (Prior to dose 1, 2 m after dose 2 & 1m after dose 3). After each dose: Solicited (d 0-3, local/general), unsolicited (d 0-30) symptoms. During whole study: SAEs
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
Hib-MenAC mixed with Tritanrix™-HepBBIOLOGICAL -
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Eligibility Criteria
Age Range56 Days — 83 Days
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion criteria: * healthy male or female, between, and including, 56 and 83 days of age. * Born after a gestation period between 36 and 42 weeks * Birth dose of hepatitis B vaccine within the first 72 hours of life Exclusion criteria: * planned administration/administration of a vaccine not f...

Countries:Thailand
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