Recent Updates
Recently added Catalysts

Influsplit SSW

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Sep 21, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00306943Annual Study for Fluarix RegistrationPHASE3 COMPLETED 120Jul 1, 2005Aug 1, 2005Sep 21, 20165 Germany
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Investigation of the humoral immune response (haemagglutination inhibiting antibodies) in subjects
Secondary Endpoints
Investigation of the safety and reactogenicity in subject's age 18 or elder past application of a doses of Influenza split vaccine 2005/2006 in relation to solicited and non-solicited incidents.
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
Influsplit SSW®BIOLOGICAL -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites5

Inclusion Criteria: * Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return, and follow-up visits) should be enrolled in the study. * All Subjects, enrolled in this study, must not been immunized agains...

Countries:Germany
Unlock Eligibility Criteria