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DTaP-IPV combined vaccine

Phase 3

Pertussis | Monoclonal antibody | Other |Sanofi|Last Updated: Apr 16, 2012

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 Enrollment442
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00319852Immunogenicity and Safety of Tetraxim Versus Local DTP + IPVPHASE3 COMPLETED 442Apr 1, 2006Jul 1, 2008Apr 16, 20121 South Korea
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Study Endpoints
Primary Endpoints
To provide information concerning the immunogenicity of Sanofi Pasteur's DTaP-IPV combined vaccine versus commercially available Biken's DTaP and Aventis Pasteur's IPV (IMOVAX POLIO) monovalent vaccines.
1 month post-vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
DTaP-IPV combined vaccineBIOLOGICAL0.5 mL, IM
DTaP vaccineBIOLOGICAL0.5 mL, IM
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Eligibility Criteria
Age Range56 Days — 70 Days
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Aged 56 to 70 days inclusive on the day of inclusion * Born at full term pregnancy (\>37 weeks) with a birth weight ≥ 2.5 kg * Informed consent form signed by the parent(s) or other legal representative * Able to attend all scheduled visits and to comply with all trial procedu...

Countries:South Korea
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