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influenza vaccine Fluarix, Adjuvanted Fluarix

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: May 8, 2017

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 Enrollment84
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00318058Safety Study of an Adjuvanted Candidate Influenza Vaccine to Prevent Influenza Disease in the Elderly PopulationPHASE1 COMPLETED 84Oct 3, 2005Nov 4, 2005May 8, 20171 Belgium
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Study Endpoints
Primary Endpoints
Percentage, intensity and relationship to vaccination of local (at the injection site) and general signs and symptoms during a 21 day follow-up period after vaccination
Occurrence of serious adverse events during the entire study.
Secondary Endpoints
evaluation of the humoral immune response (haemagglutinin antibody titre) and cellular mediated immune response
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
influenza vaccine Fluarix, Adjuvanted FluarixBIOLOGICAL -
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Eligibility Criteria
Age Range65 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * A male or female aged over 65 years at the time of the revaccination; who previously received the adjuvanted candidate vaccine or Fluarix during a clinical study organized during the preceeding year Exclusion Criteria: * Use of any investigational or non-registered product (...

Countries:Belgium
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