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MF59 adjuvanted H5N1 influenza vaccine

Phase 2

Influenza | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Dec 1, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

MF59 adjuvanted H5N1 influenza vaccine · 1 trial · 1 indication

Phase 2 1
NCT00382187Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in AdultsInfluenza
COMPLETED40 Analytics
PHASE2COMPLETED
Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in Adults
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

CPMP criteria for evaluation of flu vaccines e.g. Seroprotection, GMT's and Seroconversion rate at day 0 and day 22 and day 43 following vaccination.
day 1 to day 43

Secondary Endpoints

Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Throughout the Study.
Day 1 to Day 382
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
MF59 adjuvant H5N1 influenza vaccine 7.5 microgramsEXPERIMENTAL -
MF59 adjuvant H5N1 influenza vaccine 15 microgramsEXPERIMENTAL -
non-adjuvanted influenza vaccine 15 micrograms of H5N1 antigenEXPERIMENTAL -

Interventions

NameTypeDescription
MF59 adjuvanted H5N1 influenza vaccineBIOLOGICAL* MF59 adjuvanted (H5N1) influenza vaccine (Vietnam strain) containing 7.5 mg or 15 mg of H5N1 * non-adjuvanted influenza vaccine containing 15 ug of H5N1
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and female volunteers 18-60 years of age Exclusion Criteria: * Any auto-immune disease or other serious acute, chronic or progressive disease * Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other compo...

Countries:Italy
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Frequently asked questions about MF59 adjuvanted H5N1 influenza vaccine

What is MF59 adjuvanted H5N1 influenza vaccine used for?

MF59 adjuvanted H5N1 influenza vaccine is an investigational vaccine being developed for influenza. It is designed to generate an immune response against the H5N1 influenza virus strain. The vaccine is currently in clinical development and has not been approved by regulatory authorities.

Who makes MF59 adjuvanted H5N1 influenza vaccine?

MF59 adjuvanted H5N1 influenza vaccine is being developed by Novartis AG, which trades under the ticker NVS. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in adults.

What phase is MF59 adjuvanted H5N1 influenza vaccine in?

MF59 adjuvanted H5N1 influenza vaccine is in Phase 2 clinical development. It is an investigational vaccine, meaning it has not yet been approved for commercial use. The Phase 2 trial has been completed, and the vaccine remains under evaluation.

What clinical trials is MF59 adjuvanted H5N1 influenza vaccine in?

MF59 adjuvanted H5N1 influenza vaccine has one completed clinical trial, NCT00382187, titled 'Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in Adults.' This Phase 2 trial enrolled 40 healthy adult volunteers in Italy and evaluated the vaccine's safety and immune response.

Is MF59 adjuvanted H5N1 influenza vaccine the same as an adjuvanted pandemic flu vaccine?

MF59 adjuvanted H5N1 influenza vaccine is a specific formulation that includes the MF59 adjuvant to enhance immune response. It is designed for H5N1 influenza, a strain with pandemic potential. The vaccine is distinct from seasonal flu vaccines and is being studied for its ability to protect against this particular strain.