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Mtb72F/AS02.

Phase 2

Tuberculosis (TB) | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: May 30, 2017

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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment88
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00146744Safety and Immunogenicity of GSK Biological's Candidate Tuberculosis Vaccine Mtb72F/AS02A in Healthy PPD-positive AdultsPHASE2 COMPLETED 38Jul 1, 2005May 1, 2006May 30, 20171 Switzerland
NCT00291889Safety and Immunogenicity of GSK Biological's Candidate Tuberculosis Vaccine Mtb72F/AS02 in Healthy PPD-negative Adults.PHASE1 COMPLETED 50Jul 1, 2004May 1, 2005May 30, 20171 Belgium
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Study Endpoints
Primary Endpoints
Occurrence of solicited symptoms during the 7-day follow-up period, unsolicited symptoms during the 30-day follow-up period, grade 3 vaccine related local and general symptoms during the 30-day follow-up and serious adverse events during the entire study
Secondary Endpoints
Immunogenicity as assessed by humoral and CMI response.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
Mtb72F/AS02ABIOLOGICAL -
Mtb72F/AS02.BIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

INCLUSION CRITERIA * Written informed consent * Healthy PPD-positive volunteers aged 18 to 50 years * No active pulmonary disease as confirmed by chest X-ray * No history of extrapulmonary TB * Seronegative for HIV 1 and 2, HBsAg, and HCV * Clinically normal laboratory values for creatinine, alanin...

Countries:SwitzerlandBelgium
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Competitive Landscape -Tuberculosis 7 trials