Recent Updates
Recently added Catalysts

REPEVAX after REVAXIS

Phase 3

Healthy Adult | Monoclonal antibody | Other |Sanofi|Last Updated: Sep 11, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment500
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00400309Safety of REPEVAX® Given One Month After REVAXIS®PHASE3 COMPLETED 500Jun 1, 2006Feb 1, 2007Sep 11, 20174 France
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
injection sites reactions and systemic events during the 7 day-safety period post-vaccination with TdaP-IPV vaccine.
7 days
Secondary Endpoints
injection-site adverse reactions and systemic adverse events during the 14 day-safety period post-vaccination with Td-IPV vaccine, TdaP-IPV vaccine and placebo and serious adverse events
14 days
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
REPEVAX® after REVAXIS®EXPERIMENTALREVAXIS® at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28).
REPEVAX® after PlaceboACTIVE_COMPARATORPlacebo at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28).
Interventions
NameTypeDescription
REPEVAX® after REVAXIS®BIOLOGICALTetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after tetanus, diphtheria, poliomyelitis (inactivated)
REPEVAX® after PlaceboBIOLOGICALTetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after placebo
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Healthy adult, with vaccination history (by written evidence) of a minimum of 5 doses of a tetanus, diphtheria and poliomyelitis containing vaccine as recommended in the French vaccination calendar at 18 years old, and a maximum of 8 doses. * Last dose of a tetanus and/or diph...

Countries:France
Unlock Eligibility Criteria