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Pandemic influenza vaccine

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Apr 24, 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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment4,400
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00434733Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly SubjectsPHASE3 COMPLETED 4,400Jan 1, 2007 -Apr 24, 20081 Poland
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Study Endpoints
Primary Endpoints
Adverse event rate
Secondary Endpoints
Seroconversion and seroprotection after two doses of H5N1 vaccine
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
Pandemic influenza vaccineBIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Subjects 18 years of age who signed the informed consent Exclusion Criteria: * Receipt of another investigational agent within 4 weeks * Receipt of influenza vaccination for current season 2006/2007. * any acute disease or infection, history of neurological symptoms ...

Countries:Poland
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