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Novavax Quadrivalent 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-BlindCONTROLLED
Total Trials1
Total Enrollment500

FDA Designations

No designations recorded

Clinical trial landscape

Novavax Quadrivalent vaccine · 1 trial · 1 indication

Phase 2 1
NCT01561768A Study to Evaluate the Immune Response and Safety of a Seasonal Virus-Like Particle Influenza Vaccine in Healthy Young AdultsInfluenza
COMPLETED500 Analytics
PHASE2COMPLETED
A Study to Evaluate the Immune Response and Safety of a Seasonal Virus-Like Particle Influenza Vaccine in Healthy Young Adults
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Immunogenicity of 3 dose levels of the Novavax Quadrivalent vaccine based on HAI responses
Day 21
Number of Solicited and Unsolicited Adverse Events for the Novavax Quadrivalent vaccine
6 months

Secondary Endpoints

Estimate capacity of the Novavax Quadrivalent vaccines to fulfill FDA criteria (immunogenicity) for all strains in healthy, young adults
Day 21
Impact of including a fourth strain in the Novavax Quadrivalent vaccine on immune responses to other three strains
Day 21
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTAL -
Group 2EXPERIMENTAL -
Group 3EXPERIMENTAL -
Group 4EXPERIMENTAL -
Group 5EXPERIMENTAL -

Interventions

NameTypeDescription
Novavax Quadrivalent vaccineBIOLOGICALQuadrivalent VLP vaccine: low dose; intramuscular injection, deltoid
Novavax Trivalent vaccineBIOLOGICALTrivalent Dose; intramuscular injection, deltoid
cTIVBIOLOGICALPreconfigured dose; intramuscular injection, deltoid
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: 1. Healthy adult male or females, 18-64 years of age 2. Willing and able to give informed consent prior to study enrollment 3. Able to comply with study requirements 4. Women who are not post-menopausal (≥ 50 years of age and at least one year post last menses) or surgically ste...

Countries:Australia
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Frequently asked questions about Novavax Quadrivalent vaccine

What is Novavax Quadrivalent vaccine used for?

Novavax Quadrivalent vaccine is an investigational vaccine being developed for influenza. It is designed to generate an immune response against seasonal influenza in healthy young adults. The vaccine is currently in clinical development and has not been approved by regulatory authorities.

What does Novavax Quadrivalent vaccine target?

Novavax Quadrivalent vaccine targets influenza viruses. It is a virus-like particle vaccine intended to stimulate the immune system to recognize and respond to seasonal influenza strains. The vaccine is being studied for its ability to produce an immune response and its safety profile in healthy adults.

Who makes Novavax Quadrivalent vaccine?

Novavax Quadrivalent vaccine is developed by Novavax, Inc., a biotechnology company traded on the NASDAQ under the ticker NVAX. The company is conducting clinical research to evaluate the vaccine's safety and immunogenicity for the prevention of influenza.

What phase is Novavax Quadrivalent vaccine in?

Novavax Quadrivalent vaccine is in Phase 2 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory agencies. The vaccine is being studied in a completed Phase 2 trial to assess its immune response and safety in healthy young adults.

What clinical trials is Novavax Quadrivalent vaccine in?

Novavax Quadrivalent vaccine has one completed Phase 2 clinical trial registered as NCT01561768. This randomized, double-blind, controlled study evaluated the immune response and safety of a seasonal virus-like particle influenza vaccine in 500 healthy young adults aged 18 years and older in Australia.