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DT5aP-IPV-Hib 5-component Pertussis vaccine

Phase 3

Pertussis | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Jan 7, 2015

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
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment807
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00287092Comparison of Safety and Immunogenicity of Pediacel™ and Infanrix™ IPV+Hib (Penta) Given in a 3 Dose Schedule in InfantsPHASE3 COMPLETED 807 — — Feb 1, 2006Sep 1, 2008Jan 7, 201514 Finland, Sweden
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Study Endpoints
Primary Endpoints
To provide information concerning the immunogenicity of PEDIACEL® Vaccine.
1 Month post-dose 3
Secondary Endpoints
To provide information concerning the safety after administration of PEDIACEL® Vaccine
Entire study period
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1EXPERIMENTALParticipants will receive PEDIACEL vaccine
Group 2ACTIVE_COMPARATORParticipants will receive Infanrix-IPV+Hib vaccines
Interventions
NameTypeDescription
DT5aP-IPV-Hib 5-component Pertussis vaccineBIOLOGICAL0.5 mL, IM
Infanrix® -IPV+HibBIOLOGICAL0.5 mL, IM
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Eligibility Criteria
Age Range80 Days — 120 Days
SexALL
Healthy VolunteersYes
Study Sites14

Inclusion Criteria: * Infants aged 80 to 120 days inclusive on the day of inclusion. * Born at full term of pregnancy (\> 37 weeks) * Informed consent form signed by the parent(s) or other legal representative according to local regulations * Parent(s) or legal representative able to attend all sch...

Countries:FinlandSweden
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