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Influenza VLP Vaccine

Phase 2

Influenza | Monoclonal antibody | Infectious Disease |Novavax, Inc.|Last Updated: Jul 18, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment784

FDA Designations

No designations recorded

Clinical trial landscape

Influenza VLP Vaccine · 3 trials · 2 indications

Phase 2 3
NCT01014806Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine in Older AdultsInfluenza
COMPLETED467 Analytics
NCT00903552Trial to Evaluate Safety and Immunogenicity of Trivalent Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant)Seasonal Influenza
COMPLETED221 Analytics
NCT00754455Evaluate the Safety and Immunogenicity of a Seasonal Influenza VLP Vaccine (Recombinant) in Healthy AdultsInfluenza
COMPLETED317 Analytics
PHASE2COMPLETED
Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine in Older Adults
InfluenzaUnlock trial analytics
PHASE2COMPLETED
Trial to Evaluate Safety and Immunogenicity of Trivalent Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant)
Seasonal InfluenzaUnlock trial analytics
PHASE2COMPLETED
Evaluate the Safety and Immunogenicity of a Seasonal Influenza VLP Vaccine (Recombinant) in Healthy Adults
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse Events (AEs)
0-21 days
Immunogenicity by HAI
21 Days
To assess the tolerability and safety of the Influenza VLP Vaccine
10 days, 6 months
The Influenza VLP Vaccine will be immunogenic
22 days
To assess the tolerability and safety of Influenza VLP Vaccine
6 Months
To assess the immunogenicity of Influenza VLP Vaccine as measured by hemagglutination inhibition (HAI) antibody titers to each of the component viral strains
Day 22

Secondary Endpoints

Immunogenicity by HAI compared to commercially licensed TIV vaccine
21 days
Immunogenicity Against drifted strains by HAI
21 days
Immunogenicity by neuraminidase activity inhibition (NAI)
21 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Low doseEXPERIMENTAL -
High doseEXPERIMENTALInvestigational Influenza VLP Vaccine 60ug/strain
TIVACTIVE_COMPARATORTrivalent Influenza Vaccine 15ug/strain, Commercially Licenced
PBSPLACEBO_COMPARATOR -
Mid doseEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Influenza VLP VaccineBIOLOGICALSingle dose; 0.5mL
TIVBIOLOGICALTrivalent Influenza Vaccine 15ug/strain, commercially licensed
PlaceboBIOLOGICALphosphate-buffered saline (PBS)
Influenza VLP Vaccine (recombinant)BIOLOGICALSingle injection Day 0; 0.5mL
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Eligibility Criteria

Age Range60 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: 1. Healthy male or female \> 60 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 procedur...

Countries:United States
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Frequently asked questions about Influenza VLP Vaccine

What is Influenza VLP Vaccine used for?

Influenza VLP Vaccine is an investigational vaccine being developed for the prevention of influenza, including seasonal influenza. It is designed to generate an immune response against the virus. The vaccine is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Influenza VLP Vaccine?

Influenza 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 in healthy adults and older adults.

What phase is Influenza VLP Vaccine in?

Influenza VLP Vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA or other regulatory agencies. Three Phase 2 trials have been completed, with a total enrollment of 784 participants, but no active trials are currently ongoing.

What clinical trials is Influenza VLP Vaccine in?

Influenza VLP Vaccine has completed three Phase 2 clinical trials in the United States. These include NCT00754455, which enrolled 317 healthy adults aged 18 years and older, NCT00903552, which enrolled 221 adults for seasonal influenza, and NCT01014806, which enrolled 467 older adults aged 60 years and above. All trials were completed.

How does Influenza VLP Vaccine work?

Influenza VLP Vaccine is a virus-like particle vaccine that mimics the structure of the influenza virus to stimulate an immune response. It is designed to present viral antigens to the immune system without causing infection, potentially providing protection against seasonal influenza strains.