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FluLaval TF

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

FluLaval TF clinical trials

FluLaval TF · 1 trial · 1 indication

Phase 1 1
NCT00727428Immunogenicity and Safety of GSK Biologicals' FluLaval® TFInfluenza
COMPLETED110 Analytics
PHASE1COMPLETED
Immunogenicity and Safety of GSK Biologicals' FluLaval® TF
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibody against each of the 3 vaccine influenza strains
Days 0 and 21
Seroconversion Rates (SCR)
Day 21
Seroprotection Rates (SPR)
Days 0 and 21
Seroconversion Factors (SCF)
Day 21

Secondary Endpoints

Occurrence, intensity and investigator's assessment of relationship to vaccine of solicited local and general signs and symptoms
During the 4-day follow-up period after vaccination.
Occurrence, intensity, and investigator's assessment of relationship to vaccine of unsolicited local and general signs and symptoms
During the 21-day follow-up period after vaccination.
Occurrence, intensity and investigator's assessment of relationship to vaccine of SAEs and medically attended events
During the entire study period
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTAL -

Interventions

NameTypeDescription
FluLaval® TFBIOLOGICALOne IM injection.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects who the investigator believes can and will comply with the requirements of the protocol * Male and female adults, 18 to 60 years of age. * Written informed consent obtained from the subject. * Satisfactory baseline medical assessment by history and physical examinatio...

Countries:Belgium
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Frequently asked questions about FluLaval TF

What is FluLaval TF?

FluLaval TF is an investigational monoclonal antibody being developed by GSK plc for influenza. It is in Phase 1 clinical development and is not an approved product. The only recorded clinical study of FluLaval TF was an immunogenicity and safety trial conducted in Belgium in healthy adult volunteers aged 18 years and older.

What is FluLaval TF used for?

FluLaval TF is being studied for influenza, an infectious disease. Development is at the Phase 1 stage, so the asset remains investigational and has no approved indication. The single completed trial enrolled 110 healthy adult volunteers in Belgium to assess immunogenicity and safety.

Who makes FluLaval TF?

FluLaval TF is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase 1 study of the monoclonal antibody in influenza. No other developer or partner is associated with the asset in the available record.

What phase is FluLaval TF in?

FluLaval TF is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The program has not advanced beyond early clinical testing, and FluLaval TF is not an approved therapy for influenza.

What clinical trials is FluLaval TF in?

FluLaval TF has been studied in one clinical trial, NCT00727428, titled Immunogenicity and Safety of GSK Biologicals' FluLaval TF. The Phase 1 study enrolled 110 healthy adult volunteers in Belgium, included both sexes, and has completed. It was an uncontrolled trial without randomization or blinding.

Is FluLaval TF the same as FluLaval?

FluLaval TF is also written as FluLaval TF with the registered trademark symbol. The TF designation distinguishes this monoclonal antibody asset from other products sharing the FluLaval name. FluLaval TF is an investigational Phase 1 monoclonal antibody for influenza developed by GSK plc.