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Prophylaxis: Diphtheria, tetanus and pertussis

Phase 3

Acellular Pertussis | Monoclonal antibody | Other |GSK plc|Last Updated: Sep 15, 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
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment321
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00263679Assessment of GSK Biologicals' Tdap Candidate Vaccine Administered as a Booster (6th Dose) in Terms of Immunogenicity and Safety to Children and Adolescents Previously Vaccinated With Five Doses of an Acellular Pertussis-containing Vaccine.PHASE3 COMPLETED 321Nov 1, 2003Oct 1, 2004Sep 15, 201613 Germany
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Study Endpoints
Primary Endpoints
Safety after vaccination.
Secondary Endpoints
Immunogenicity and safety after vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
Prophylaxis: Diphtheria, tetanus and pertussisBIOLOGICAL -
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Eligibility Criteria
Age Range9 Years — 13 Years
SexALL
Healthy VolunteersYes
Study Sites13

Inclusion Criteria: \- Subjects previously enrolled and vaccinated in GSK Biologicals' studies APV-118 and APV-120 and who were 9 through 13 years of age Exclusion Criteria: * Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the a...

Countries:Germany
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