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A/H1N1 2009 Influenza VLP Vaccine

Phase 2

Seasonal Influenza | Monoclonal antibody | Infectious Disease |Novavax, Inc.|Last Updated: Apr 25, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment4,560

FDA Designations

FAST_TRACK

Clinical trial landscape

A/H1N1 2009 Influenza VLP Vaccine · 1 trial · 1 indication

Phase 2 1
NCT01072799Safety and Immunogenicity of an A (H1N1) 2009 Influenza Virus-like Particle (VLP) VaccineSeasonal Influenza
COMPLETED4,560 Analytics
PHASE2COMPLETED
Safety and Immunogenicity of an A (H1N1) 2009 Influenza Virus-like Particle (VLP) Vaccine
Seasonal Influenza
NCT010727994,560
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Study Endpoints

Primary Endpoints

Safety and tolerability of two injections of A (H1N1) 2009 influenza VLP vaccine
35 days

Secondary Endpoints

Evaluation of immunogenicity of two injections of A (H1N1) 2009 influenza VLP vaccine by Hemagglutination Inhibition
35 days
Long-term Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMCs)
6 months post second dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Low dose H1N1EXPERIMENTAL -
Mid dose H1N1EXPERIMENTAL -
High dose H1N1EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PlaceboBIOLOGICALTwo doses (Day 1 and Day 22); 0.5mL
A/H1N1 2009 Influenza VLP VaccineBIOLOGICALTwo doses (Day 1 \& Day 22); 0.5mL
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male or female 18-64 years of age at the time of the vaccination. 2. Informed consent must be obtained from the subject prior to beginning any study specific procedures indicating that they understand the purpose of this study and are willing to adhere to the procedures descr...

Countries:Mexico
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Frequently asked questions about A/H1N1 2009 Influenza VLP Vaccine

What is A/H1N1 2009 Influenza VLP Vaccine used for?

A/H1N1 2009 Influenza VLP Vaccine is used for seasonal influenza, an infectious disease. It is a virus-like particle vaccine developed by Novavax, Inc. (NVAX) and is currently in Phase 2 clinical development. The vaccine is designed to prevent influenza caused by the A/H1N1 2009 strain.

Who makes A/H1N1 2009 Influenza VLP Vaccine?

A/H1N1 2009 Influenza VLP Vaccine is being developed by Novavax, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker NVAX. The vaccine is currently in Phase 2 clinical development for seasonal influenza.

What phase is A/H1N1 2009 Influenza VLP Vaccine in?

A/H1N1 2009 Influenza VLP Vaccine is in Phase 2 clinical development. It is an investigational vaccine for seasonal influenza and has not been approved by the FDA. The vaccine has received Fast Track designation from the FDA.

What clinical trials is A/H1N1 2009 Influenza VLP Vaccine in?

A/H1N1 2009 Influenza VLP Vaccine has one completed clinical trial, NCT01072799, titled 'Safety and Immunogenicity of an A (H1N1) 2009 Influenza Virus-like Particle (VLP) Vaccine'. This Phase 2 trial enrolled 4,560 participants in Mexico, including healthy volunteers aged 18 years and older.

Is A/H1N1 2009 Influenza VLP Vaccine FDA approved?

A/H1N1 2009 Influenza VLP Vaccine is not FDA approved. It is an investigational vaccine currently in Phase 2 clinical development for seasonal influenza. The FDA has granted Fast Track designation to the vaccine, which is intended to expedite its development and review.