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FluLaval TF

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: May 8, 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
UNCONTROLLED
Total Trials1
Total Enrollment110
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00727428Immunogenicity and Safety of GSK Biologicals' FluLaval® TFPHASE1 COMPLETED 110 — — Aug 5, 2008Feb 17, 2009May 8, 20171 Belgium
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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 — 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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Competitive Landscape -Influenza 16 trials
CompanyTickerTrialsLead PhaseDrugs
Sinovac Biotech Ltd.SVA1PHASE3Participants will receive one dose of vaccine of Sinovac QIV, Vaxigrip QIV
GSK plc Sponsored ADRGSK3PHASE2Flu mRNA, Comparator 1, Comparator 2, Comparator 3, Zanamivir
Moderna, Inc.MRNA1PHASE3mRNA-1018-H5
Traws Pharma, Inc.TRAW2PHASE2TRX-100, Influenza A/France/759/2021 virus
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Sanofi SA Sponsored ADRSNY3PHASE1Trivalent messenger ribonucleic acid hemagglutinin Vaccine 1, TIV mRNA-neuraminidase, TIV mRNA-HA Vaccine 2, Quadrivalent Influenza Standard Dose Vaccine, Efluelda Tetra Pre-filled syringe
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Unity Health TorontoUBX1PHASE3Baloxavir
Pfizer Inc.PFE1 — COVID-19 Vaccine
Abbott LaboratoriesABT1NAUndisclosed
Grace Therapeutics, Inc.GRCE1NAUndisclosed
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