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trivalent split influenza vaccine

Phase 3

Seasonal Influenza | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Apr 22, 2008

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
UNCONTROLLED
Total Trials1
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00498303Safety and Immunogenicity of Trivalent Split Influenza Vaccine Using the Strain Composition 2007/2008PHASE3 COMPLETED 120Jun 1, 2007 -Apr 22, 20081 Germany
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Study Endpoints
Primary Endpoints
evaluate the antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21
evaluate safety of trivalent split influenza vaccine
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Interventions
NameTypeDescription
trivalent split influenza vaccineBIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry * available for all the visits scheduled in the study and able to comply with all study requirements * in good health as determined by: medical history, physical examination, ...

Countries:Germany
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