Recent Updates
Recently added Catalysts

H1 influenza antigen

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

H1 influenza antigen · 1 trial · 1 indication

Phase 1 1
NCT06125717Phase 1 Evaluation of H1 Influenza Vaccine Delivered by MIMIX MAPInfluenza
COMPLETED45 Analytics
PHASE1COMPLETED
Phase 1 Evaluation of H1 Influenza Vaccine Delivered by MIMIX MAP
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the safety of VX-103 delivered as a single MIMIX MAP immunization
180 Days
Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about H1 influenza antigen

What is H1 influenza antigen used for?

H1 influenza antigen is an investigational vaccine being studied for the prevention of influenza. It is currently in Phase 1 clinical development and is being evaluated in healthy volunteers aged 18 years and older. The vaccine is designed to elicit an immune response against the H1 influenza virus.

Who makes H1 influenza antigen?

H1 influenza antigen is being developed by Icon Plc, a company traded on the NASDAQ under the ticker symbol ICLR. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational influenza vaccine.

What phase is H1 influenza antigen in?

H1 influenza antigen is in Phase 1 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. A Phase 1 trial has been completed to assess its safety and immune response in healthy volunteers.

What clinical trials is H1 influenza antigen in?

H1 influenza antigen has been studied in one clinical trial, identified as NCT06125717, titled 'Phase 1 Evaluation of H1 Influenza Vaccine Delivered by MIMIX MAP'. This was a randomized, double-blind, placebo-controlled study conducted in Canada with 45 healthy adult participants. The trial has been completed.

How is H1 influenza antigen administered?

H1 influenza antigen is being evaluated as a vaccine delivered by the MIMIX MAP system, as described in the Phase 1 clinical trial NCT06125717. The study assessed the vaccine's safety and immunogenicity when administered via this delivery method in healthy volunteers.