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Influenza Vaccine

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |Abbott Laboratories|Last Updated: Aug 26, 2011

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_CONTROLLED
Total Trials1
Total Enrollment3,138
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00999206Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza VaccinePHASE3 COMPLETED 3,138Jan 1, 2010Aug 1, 2010Aug 26, 201119 Australia, New Zealand
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Study Endpoints
Primary Endpoints
Anti-HA antibody titers and derived parameters seroprotection, seroconversion and fold increase
3 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Influenza VaccineBIOLOGICALsurface antigen, inactivated, prepared in cell cultures
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites19

Inclusion Criteria 1. Female or male subjects \>= 18 years of age (adults \>= 18 to \< =60 years of age or elderly \>= 61 years of age). 2. Willing and able to give informed consent before any protocol procedures are performed. 3. Able to adhere to visit schedules and all protocol required study pr...

Countries:AustraliaNew Zealand
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