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Influenza virus vaccine 2009-2010 formulation

Phase 2

Influenza | 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment131
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00945438Study of the Influenza Vaccine (Split Virion, Inactivated) Northern Hemisphere 2009-2010 Formulation (Intradermal Route)PHASE2 COMPLETED 131May 1, 2009Jul 1, 2009Jan 14, 20142 France
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Study Endpoints
Primary Endpoints
To provide information concerning the immunogenicity of Intradermal (ID) Influenza vaccine (split virion, inactivated), NH 2009-2010 formulation.
21 days post-vaccination
To provide information concerning the safety of Intradermal (ID) Influenza vaccine (split virion, inactivated), NH 2009-2010 formulation.
21 days post-vaccination and entire study duration
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1EXPERIMENTALParticipants aged 18 to 59 years at enrollment.
Group 2EXPERIMENTALParticipants aged 60 years or older at enrollment.
Interventions
NameTypeDescription
Influenza virus vaccine 2009-2010 formulationBIOLOGICAL0.1 mL, Intradermal
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Aged 18 to 59 years (i.e., to the day before the 60th birthday) or 60 years or older (from the day of the 60th birthday) on the day of inclusion * Provision of a signed informed consent * Able to attend all scheduled visits and comply with all trial procedures * For a woman of...

Countries:France
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