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Inactivated influenza vaccine

Phase 2

Influenza | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Jan 17, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00343681A Study of the Immunogenicity and Safety of the 2006-2007 Influenza VaccinePHASE2 COMPLETED 120Jul 1, 2006Aug 1, 2007Jan 17, 20142 Switzerland, United Kingdom
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Study Endpoints
Primary Endpoints
To provide information concerning the immunogenicity of inactivated influenza vaccine (split virion)
21 Days post-vaccination
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
Inactivated influenza vaccine (split virion)BIOLOGICAL0.5 mL, Intramuscular
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Aged at least 18 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 Visit 1 * For a woman of child-bearing poten...

Countries:SwitzerlandUnited Kingdom
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