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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 Trials2
Total Enrollment4,787
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00383526Study of Inactivated, Split-Virion Influenza Vaccine Compared With the Reference Vaccine Vaxigrip® in the ElderlyPHASE3 COMPLETED 3,707Sep 1, 2006Sep 1, 2009Jan 14, 20144 Belgium, France +2
NCT00296829Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Given by an Alternate Route in the ElderlyPHASE2 COMPLETED 1,080Jan 1, 2006Feb 1, 2007Jan 14, 201411 Australia, New Zealand
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Study Endpoints
Primary Endpoints
To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza vaccine
21 days post-vaccination
Secondary Endpoints
To provide information concerning the safety of Inactivated, Split-Virion Influenza vaccine
Entire study period
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Study Group 1EXPERIMENTAL -
Study Group 2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Inactivated, split-virion influenza vaccineBIOLOGICALVaccine
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Eligibility Criteria
Age Range60 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Aged over 60 years on the day of inclusion. * Informed Consent Form signed. * Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: * Systemic hypersensitivity to egg proteins, chick proteins, or any of the vaccine components, in pa...

Countries:BelgiumFranceItalyLithuaniaAustraliaNew Zealand
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