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Surface antigen inactivated influenza vaccine

Phase 2

Influenza | 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
UNCONTROLLED
Total Trials1
Total Enrollment129
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00518453Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Formulation 2007-2008PHASE2 COMPLETED 129Jul 1, 2007Aug 1, 2007Dec 1, 20161 United Kingdom
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Study Endpoints
Primary Endpoints
evaluate the antibody response to each influenza vaccine antigen
21 days post-immunization
Secondary Endpoints
Safety and tolerability of the study vaccine in the study population
Throughout the study
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Arm 1: FluvirinEXPERIMENTAL -
Interventions
NameTypeDescription
Surface antigen inactivated influenza vaccineBIOLOGICAL1 dose of Fluvirin 2007/2008 Northern Hemisphere vaccine composition
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Eligibility Criteria
Age Range18 Years — 84 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Subjects eligible for enrollment into this study are male and female adult volunteers Exclusion Criteria: * Any serious disease

Countries:United Kingdom
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