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Pediarix TM, Infanrix penta TM

Phase 3

Diphtheria | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Sep 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
UNCONTROLLED
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00879827Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy InfantsPHASE3 COMPLETED 60Sep 1, 2000May 1, 2001Sep 7, 2016 -
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Study Endpoints
Primary Endpoints
Anti-PT, anti-FHA and anti-PRN antibody titers.
One month after the 3rd dose of the primary vaccination course
Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers
One month after the 3rd dose of the primary vaccination course
Anti-HBs antibody titers
One month after the 3rd dose of the primary vaccination course
Anti-polio virus types 1, 2 and 3 antibody titers
One month after the 3rd dose of the primary vaccination course
Anti-PRP antibody titers
One month after the 3rd dose of the primary vaccination course
Secondary Endpoints
Occurrence of solicited adverse events
During the 4-day follow-up period after each dose
Occurrence of unsolicited adverse events
During the 30-day follow-up period after each dose
Occurrence of Serious Adverse Events
Over the course of the study
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Single GroupEXPERIMENTAL -
Interventions
NameTypeDescription
Pediarix TM, Infanrix penta TMBIOLOGICALThe vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.
Hiberix TMBIOLOGICALThe vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.
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Eligibility Criteria
Age Range6 Weeks — 8 Weeks
SexALL
Healthy VolunteersYes

Inclusion Criteria: * A male or female infant between 6 and 8 weeks of age at the time of the first vaccination. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Written informed consent obtained from the parents or guard...

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