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diphtheria, tetanus, pertussis & Hib vaccine

Phase 3

Tetanus | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Oct 12, 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 Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00379977Study to Assess the Safety & Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Given at 3, 4 and 5 Months of AgePHASE3 COMPLETED 30Sep 1, 2006Dec 1, 2006Oct 12, 20161 China
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Study Endpoints
Primary Endpoints
Occurrence of solicited symptoms during the 4 days following vaccination, unsolicited symptoms during the 31 days following vaccination and serious adverse events
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Interventions
NameTypeDescription
diphtheria, tetanus, pertussis & Hib vaccineBIOLOGICAL -
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Eligibility Criteria
Age Range90 Days — 120 Days
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * A male or female between, and including, 90 and 120 days of age at the time of the first vaccination Written informed consent obtained from the parent or guardian of the subject Exclusion Criteria: * subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemo...

Countries:China
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