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MF59 H1N1 vaccine

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Aug 8, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment175

FDA Designations

No designations recorded

Clinical trial landscape

MF59 H1N1 vaccine · 1 trial · 1 indication

Phase 1 1
NCT00943358Safety and Immunogenicity of A/H1N1v Vaccines in Healthy AdultsInfluenza
COMPLETED175 Analytics
PHASE1COMPLETED
Safety and Immunogenicity of A/H1N1v Vaccines in Healthy Adults
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

GMT antibody rises
42 days

Secondary Endpoints

frequency of adverse reactions
42 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
VaccineACTIVE_COMPARATORadjuvanted influenza vaccine
Vaccine 2ACTIVE_COMPARATORnon-adjuvanted vaccine

Interventions

NameTypeDescription
MF59 H1N1 vaccineBIOLOGICAL3.75-7.5ug dose
Plain H1N1 vaccineBIOLOGICAL7.5-15ug
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Mentally competent adults, who have signed an informed consent form after having received a detailed explanation of the study protocol. 2. Male or female subjects 18-50 years who are either healthy or have a stable medical condition. 3. Able to understand and comply with all ...

Countries:United Kingdom
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Frequently asked questions about MF59 H1N1 vaccine

What is MF59 H1N1 vaccine used for?

MF59 H1N1 vaccine is an investigational vaccine being studied for the prevention of influenza. It is currently in Phase 1 clinical development, meaning it has not yet been approved for use. The vaccine is designed to generate an immune response against the H1N1 strain of the influenza virus.

Who makes MF59 H1N1 vaccine?

MF59 H1N1 vaccine is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational vaccine.

What phase is MF59 H1N1 vaccine in?

MF59 H1N1 vaccine is in Phase 1 clinical development. This early-stage trial is designed to assess the safety and immune response of the vaccine in healthy adults. The vaccine is investigational and has not received regulatory approval for public use.

What clinical trials is MF59 H1N1 vaccine in?

MF59 H1N1 vaccine has one completed clinical trial registered as NCT00943358, titled 'Safety and Immunogenicity of A/H1N1v Vaccines in Healthy Adults.' This Phase 1 study enrolled 175 participants in the United Kingdom and evaluated the vaccine's safety and immunogenicity in healthy adults aged 18 years and older.

Is MF59 H1N1 vaccine the same as an H1N1 vaccine?

MF59 H1N1 vaccine is a specific investigational vaccine formulation targeting the H1N1 influenza strain. It is being studied as a potential vaccine for influenza, but it is not yet approved. The vaccine is distinct from other H1N1 vaccines due to its specific formulation and development by Novartis.