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H5N1 VLP Vaccine

Phase 1

Pandemic Influenza | Vaccine | Infectious Disease |Novavax, Inc.|Trials Updated: Jun 21, 2013

H5N1 VLP Vaccine development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment230

FDA Designations

No designations recorded

H5N1 VLP Vaccine clinical trials

H5N1 VLP Vaccine · 1 trial · 1 indication

Phase 1 1
NCT00519389Safety, Reactogenicity and Immunogenicity of an H5N1 VLPPandemic Influenza
COMPLETED230 Analytics
PHASE1COMPLETED
Safety, Reactogenicity and Immunogenicity of an H5N1 VLP
Pandemic InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and reactogenicity of H5N1 VLP Vaccine
6 months

Secondary Endpoints

Immunogenicity of H5N1 VLP Influenza vaccine
6 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Low dose H5N1 VLP VaccineEXPERIMENTAL -
Mid dose H5N1 VLP VaccineEXPERIMENTAL -
High dose H5N1 VLP VaccineEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
H5N1 VLP VaccineBIOLOGICALTwo doses - Day 0 \& Day 28
PlaceboBIOLOGICALTwo doses - Day 0 \& Day 28
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male or female 18 to 40 years of age at the time of the vaccination. 2. Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visits and completion of the data collection tool). 3. Available by telephone. ...

Countries:United States
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Frequently asked questions about H5N1 VLP Vaccine

What is the H5N1 VLP Vaccine?

The H5N1 VLP Vaccine is an investigational vaccine developed by Novavax, Inc. for pandemic influenza. It is a virus-like particle (VLP) vaccine designed to protect against H5N1 influenza, a strain with pandemic potential. It has been studied in a Phase 1 clinical trial.

What is the H5N1 VLP Vaccine used for?

The H5N1 VLP Vaccine is being developed for the prevention of pandemic influenza caused by the H5N1 virus. It is intended to stimulate an immune response against H5N1 influenza. The vaccine is investigational and has been evaluated in a Phase 1 trial.

Who makes the H5N1 VLP Vaccine?

The H5N1 VLP Vaccine is developed by Novavax, Inc., a biotechnology company traded on the Nasdaq under the ticker symbol NVAX. Novavax specializes in vaccine development, including virus-like particle (VLP) and recombinant protein technologies.

What phase is the H5N1 VLP Vaccine in?

The H5N1 VLP Vaccine is in Phase 1 clinical development. It has completed one Phase 1 trial (NCT00519389) evaluating its safety, reactogenicity, and immunogenicity. It is not approved by the FDA and remains investigational.

What clinical trials is the H5N1 VLP Vaccine in?

The H5N1 VLP Vaccine has been studied in one completed Phase 1 clinical trial, NCT00519389, titled "Safety, Reactogenicity and Immunogenicity of an H5N1 VLP." The trial enrolled 230 healthy adult volunteers in the United States and was randomized, double-blind, and placebo-controlled.