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BEGRIVAC

Phase 3

Seasonal Influenza | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Jan 5, 2012

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 Enrollment142
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01147081Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2010/2011PHASE3 COMPLETED 142Jun 1, 2010Jul 1, 2010Jan 5, 20123 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 1 and on Day 22, and evaluation of safety of Begrivac
22 days (-1/+5)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTAL -
Interventions
NameTypeDescription
BEGRIVACBIOLOGICAL126 healthy subjects enrolled to receive, in open-label manner, one dose of Begrivax (influenza vaccine)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: 1. Male and female volunteers of 18 years of age and older, mentally competent, willing and able to give written informed consent prior to study entry; 2. Individuals able to comply with all the study requirements; 3. Individuals in good health as determined by medical history, ...

Countries:Germany
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