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VAL-339851

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |Moderna, Inc.|Last Updated: Jan 11, 2021

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment156
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03345043Safety, Tolerability, and Immunogenicity of VAL-339851 in Healthy Adult SubjectsPHASE1 COMPLETED 156 — — May 11, 2016Aug 13, 2018Jan 11, 20211 United States
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Study Endpoints
Primary Endpoints
Frequency of solicited AEs (local and systemic reactogenicity events)
7 days following each dose administration
Frequency of unsolicited adverse events
21 days following each dose administration
Frequency of serious adverse events (SAE), adverse events of special interest (AESI), medically-attended AEs, and new onset of chronic illness
One year after last dose administration
Secondary Endpoints
Titers of hemagglutinin inhibition (HAI) and microneutralization antibodies in comparison with baseline sample
One year after last dose administration
Seroconversion rates in comparison to baseline samples
One year after last dose administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
VAL-339851EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
VAL-339851BIOLOGICALEscalating dose levels
PlaceboOTHERSaline
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Eligibility Criteria
Age Range18 Years — 49 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Agrees to comply with the study procedures and provides written informed consent * 18 to 49 years of age * Body mass index between 18 and 35 kg/m2 * Negative urine pregnancy test at the Screening visit and the day of each vaccination for females of childbearing potential. * Fe...

Countries:United States
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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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