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H5N1 VLP Vaccine

Phase 1

Pandemic Influenza | Monoclonal antibody | Infectious Disease |Novavax, Inc.|Last Updated: Jun 21, 2013

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

Clinical trial landscape

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 H5N1 VLP Vaccine used for?

H5N1 VLP Vaccine is an investigational vaccine being developed for pandemic influenza. It is designed to protect against H5N1 influenza, a strain that has pandemic potential. The vaccine is currently in clinical development and has not been approved for commercial use.

Who makes H5N1 VLP Vaccine?

H5N1 VLP Vaccine is being developed by Novavax, Inc., a biotechnology company traded on the Nasdaq under the ticker symbol NVAX. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity for pandemic influenza.

What phase is H5N1 VLP Vaccine in?

H5N1 VLP Vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine remains under investigation for pandemic influenza.

What clinical trials is H5N1 VLP Vaccine in?

H5N1 VLP Vaccine has one completed clinical trial, identified as NCT00519389, titled 'Safety, Reactogenicity and Immunogenicity of an H5N1 VLP.' This Phase 1 trial enrolled 230 participants in the United States and evaluated the vaccine in healthy volunteers aged 18 years and older.

Is H5N1 VLP Vaccine the same as a monoclonal antibody?

No, H5N1 VLP Vaccine is not a monoclonal antibody. Although the modality is listed as monoclonal antibody, the vaccine is a virus-like particle (VLP) vaccine designed to elicit an immune response against H5N1 influenza. It is an investigational vaccine, not a therapeutic antibody.