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Monovalent inactivated influenza vaccine

Phase 3

Pre-pandemic Influenza Vaccine | 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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment240
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00848029Safety and Immunogenicity of Two Doses of Monovalent Inactivated Influenza Vaccine That is Adjuvanted With MF59C.1 (MF59) and Uses a Surface Antigen From a Potential Pandemic Virus Strain Candidate (H5N1) in Adult and Elderly Subjects Using Four Different Vaccination SchedulesPHASE3 COMPLETED 240 — — Nov 1, 2008Jun 1, 2009Dec 1, 20161 Czechia
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Study Endpoints
Primary Endpoints
Evaluation of antibody response to a monovalent inactivated influenza vaccine adjuvanted with MF59 and uses a surface antigen from a potential pandemic homologous virus strain candidate (H5N1).
6 months
Secondary Endpoints
Evaluation of safety of the monovalent inactivated influenza vaccine that is adjuvanted with MF59C.1 (MF59) and uses a surface antigen from a potential pandemic virus strain candidate (H5N1) in Adult Subjects.
6 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
Monovalent inactivated influenza vaccineBIOLOGICALTwo doses of monovalent inactivated influenza adjuvanted vaccine
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects aged 18 to 60 years of age who are mentally competent and who have signed an informed consent form after having received a detailed explanation of the study protocol; * In good health as determined by: * Medical history, * Physical examination, * Clinical judgm...

Countries:Czechia
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