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Inactivated Split-virion influenza vaccine

Phase 3

Orthomyxoviridae Infection | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Jan 14, 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
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment2,256
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00383539Lot-to-Lot Consistency Study of the Investigational, Inactivated, Split-Virion Influenza Vaccine in AdultsPHASE3 COMPLETED 2,256 — — Sep 1, 2006Dec 1, 2007Jan 14, 20144 France, Lithuania +2
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Study Endpoints
Primary Endpoints
To provide information concerning the immunogenicity of an inactivated, split-virion influenza vaccine
21 Days pot-vaccination
Secondary Endpoints
To provide information concerning the safety of an inactivated, split-virion influenza vaccine.
6 months post-vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTALLot 1
2EXPERIMENTALLot 2
3EXPERIMENTALLot 3
4ACTIVE_COMPARATORControl
Interventions
NameTypeDescription
Inactivated Split-virion influenza vaccineBIOLOGICALVaccine Lot 1
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria : * Aged 18 to 60 years on the day of inclusion. * Informed consent form signed. * Able to attend all scheduled visits and to comply with all trial procedures. * For a woman, inability to bear a child or negative urine pregnancy test at the first visit. Exclusion Criteria : * S...

Countries:FranceLithuaniaSpainUnited Kingdom
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