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Influenza Vaccine, Formulation 2008-2009

Phase 2

Seasonal Influenza | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Dec 1, 2016

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 Enrollment133
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00748813Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine Using the Strain Composition 2008/2009PHASE2 COMPLETED 133Jun 1, 2008Jul 1, 2008Dec 1, 20163 Italy
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Study Endpoints
Primary Endpoints
Evaluation of antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) test on Day 0 and on Day 21
21 days (-1/+5)
Secondary Endpoints
Evaluation of safety
21 days (-1/+5)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1OTHER -
Interventions
NameTypeDescription
Influenza Vaccine, Formulation 2008-2009BIOLOGICAL1 dose of Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2008-2009
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Subjects eligible for enrollment into this study are male and female adults who are: 1. ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry 2. able to comply with all study requirements 3. in good health as determined by...

Countries:Italy
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