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FluLaval TF

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |GSK plc|Last 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

Clinical trial landscape

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 used for?

FluLaval TF is an investigational vaccine being studied for the prevention of influenza. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The vaccine is being evaluated for its immunogenicity and safety in healthy adults.

Who makes FluLaval TF?

FluLaval TF is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immune response in healthy adults.

What phase is FluLaval TF in?

FluLaval TF is currently in Phase 1 clinical development. It is an investigational vaccine and has not yet received regulatory approval. The Phase 1 trial has been completed, and the vaccine remains under investigation for the prevention of influenza.

What clinical trials is FluLaval TF in?

FluLaval TF has one completed Phase 1 clinical trial, identified as NCT00727428. This study, titled "Immunogenicity and Safety of GSK Biologicals' FluLaval® TF," enrolled 110 healthy adults aged 18 years and older in Belgium. The trial was uncontrolled and not randomized or double-blinded.

Is FluLaval TF the same as FluLaval?

FluLaval TF is a formulation of the influenza vaccine FluLaval, developed by GSK. The "TF" designation indicates a specific formulation being studied in clinical trials. While related to FluLaval, FluLaval TF is an investigational vaccine and has not been approved for use.