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Poliomyelitis Vaccine inactivated

Phase 3

Poliomyelitis | Monoclonal antibody | Other |Sanofi|Last Updated: Jan 22, 2014

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 Enrollment600
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00348387Immunogenicity and Safety of Imovax Polio in Chinese Infants Compared to Local OPVPHASE3 COMPLETED 600Jun 1, 2006Dec 1, 2008Jan 22, 20142 China
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Study Endpoints
Primary Endpoints
To provide information concerning the immunogenicity of IMOVAX Polio™ vaccine
1 month post-vaccination 3
Secondary Endpoints
To provide information concerning the safety of IMOVAX Polio™ vaccine
Entire study period
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1EXPERIMENTAL -
Group 2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Poliomyelitis Vaccine inactivatedBIOLOGICAL0.5 mL, Intramuscular
Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)BIOLOGICAL1g dragee, oral
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Eligibility Criteria
Age Range60 Days — 70 Days
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Aged 2 months (60-70 days) on the day of inclusion into the study * Born at full term pregnancy ( over 36 weeks) with a birth weight ≥ 2.5 kg 2Ibs) or more * Parent(s) or legal representative able to understand and give authorization and sign informed consent for participation...

Countries:China
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