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Influenza

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Mar 23, 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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials3
Total Enrollment8,720
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00380211Safety and Immunogenicity of FluLaval™ TR and Fluarix® (Influenza Vaccines) in Young and Older AdultsPHASE3 COMPLETED 660Sep 1, 2006Nov 1, 2006Oct 7, 20166 United States
NCT00197288Study Comparing the Immune Response of Fluarix and Fluzone Influenza VaccinesPHASE3 COMPLETED 1,847Oct 1, 2005Jun 1, 2006Jan 18, 201715 United States
NCT00197223Post-marketing Study to Evaluate the Efficacy of Influenza VaccinePHASE3 COMPLETED 6,213Sep 1, 2005May 1, 2006Mar 23, 20171 Czechia
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Study Endpoints
Primary Endpoints
21 days after vaccination: seroconversion rate, seroprotection rate,
geometric mean titer fold increase
Immunological non-inferiority (GMT & seroconversion rates) of Fluarix vs Fluzone 21 days post-vaccination in adults (18 yrs)
Incidence of culture confirmed influenza A and/or B during the surveillance period
Secondary Endpoints
Immediate AEs; solicited and spontaneous AEs within 42 days of vaccination;
SAEs over the whole study period
Non-inferiority of Fluarix vs Fluzone 21 days post-vacc in elderly (>65 yrs)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
Influenza vaccine (A/H3N2, A/H1N1, and B strains)BIOLOGICAL -
FluarixBIOLOGICAL -
InfluenzaBIOLOGICAL -
Influenza vaccineBIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: * Male or female adults (≥18 yrs) * Stable health status * Provide informed consent * Access to direct phone service (NOT a pay phone or a common-use phone service) * Eligible females must have a negative pregnancy test Exclusion Criteria: * Febrile illness (\>38.0°C oral temp...

Countries:United StatesCzechia
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