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REVAXIS

Phase 3

Diphtheria | Monoclonal antibody | Other |Sanofi|Last Updated: Sep 11, 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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment760
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00447525REVAXIS® Versus DT Polio® as a Second Booster in 6 Year-old ChildrenPHASE3 COMPLETED 760Feb 1, 2007Jan 1, 2008Sep 11, 201764 France
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
REVAXIS®BIOLOGICAL -
DT-Polio®BIOLOGICAL -
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Eligibility Criteria
Age Range6 Years — 6 Years
SexALL
Healthy VolunteersYes
Study Sites64

Inclusion Criteria: 1. Healthy child without chronic severe disease of either gender, 2. 6 year-old child on vaccination day, 3. Child previously vaccinated with three doses of a diphtheria, tetanus and poliomyelitis containing vaccine given alone or in combination within the first 6 months of life...

Countries:France
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