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Influsplit SSW

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

Influsplit SSW · 1 trial · 1 indication

Phase 3 1
NCT00306943Annual Study for Fluarix RegistrationInfluenza
COMPLETED120 Analytics
PHASE3COMPLETED
Annual Study for Fluarix Registration
InfluenzaUnlock trial analytics

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.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
Influsplit SSW®BIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about Influsplit SSW

What is Influsplit SSW used for?

Influsplit SSW is an investigational monoclonal antibody being developed for influenza, a viral infection of the respiratory tract. It is currently in Phase 3 clinical development, meaning it has not yet been approved and is still being studied for safety and effectiveness.

Who makes Influsplit SSW?

Influsplit SSW is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's potential as a treatment for influenza.

What phase is Influsplit SSW in?

Influsplit SSW is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy for treating influenza.

What clinical trials is Influsplit SSW in?

Influsplit SSW has one completed Phase 3 clinical trial with the identifier NCT00306943, titled 'Annual Study for Fluarix Registration.' This trial enrolled 120 participants with influenza in Germany and included healthy volunteers aged 18 years and older.

Is Influsplit SSW FDA approved?

Influsplit SSW is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for influenza. The drug has completed one clinical trial, but it remains under study and has not yet received regulatory approval.