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H1 influenza antigen

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |Icon Plc|Last Updated: Nov 9, 2023

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_CONTROLLED
Total Trials1
Total Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06125717Phase 1 Evaluation of H1 Influenza Vaccine Delivered by MIMIX MAPPHASE1 COMPLETED 45Jul 2, 2022Mar 13, 2023Nov 9, 20233 Canada
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Study Endpoints
Primary Endpoints
To determine the safety of VX-103 delivered as a single MIMIX MAP immunization
180 Days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelFACTORIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
15 μg of the H1 influenza antigenACTIVE_COMPARATOR -
7.5 μg of the H1 influenza antigenACTIVE_COMPARATOR -
Placebo (no antigen)PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
H1 influenza antigenBIOLOGICALEither 7.5 μg or 15 μg of the H1 influenza antigen
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Eligibility Criteria
Age Range18 Years — 39 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Male or female aged 18 - 39 years inclusive * Provide written informed consent to participate * Healthy participants without acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality o As determined by medical history, physi...

Countries:Canada
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