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inactivated split influenza vaccine

Phase 3

Seasonal Influenza | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Apr 7, 2017

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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment126
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00945841Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010PHASE3 COMPLETED 126Jun 1, 2009Jun 1, 2009Apr 7, 20173 Germany
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Study Endpoints
Primary Endpoints
Evaluation of antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21
21 days (-1/+7)
Evaluation of safety of inactivated split influenza vaccine
21 days (-1/+7)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1OTHER -
Interventions
NameTypeDescription
inactivated split influenza vaccineBIOLOGICAL1 dose of inactivated split influenza vaccine, using the strain composition 2009/2010
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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: * M...

Countries:Germany
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