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MF59 H1N1 vaccine

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Aug 8, 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
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment175
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00943358Safety and Immunogenicity of A/H1N1v Vaccines in Healthy AdultsPHASE1 COMPLETED 175Jul 1, 2009Dec 1, 2009Aug 8, 20121 United Kingdom
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Study Endpoints
Primary Endpoints
GMT antibody rises
42 days
Secondary Endpoints
frequency of adverse reactions
42 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
VaccineACTIVE_COMPARATORadjuvanted influenza vaccine
Vaccine 2ACTIVE_COMPARATORnon-adjuvanted vaccine
Interventions
NameTypeDescription
MF59 H1N1 vaccineBIOLOGICAL3.75-7.5ug dose
Plain H1N1 vaccineBIOLOGICAL7.5-15ug
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Mentally competent adults, who have signed an informed consent form after having received a detailed explanation of the study protocol. 2. Male or female subjects 18-50 years who are either healthy or have a stable medical condition. 3. Able to understand and comply with all ...

Countries:United Kingdom
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