Recent Updates
Recently added Catalysts

Novavax Quadrivalent vaccine

Phase 2

Influenza | Vaccine | Infectious Disease |Novavax, Inc.|Trials Updated: Jul 18, 2013

Novavax Quadrivalent vaccine development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Mar 2012

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment500

FDA Designations

No designations recorded

Novavax Quadrivalent vaccine clinical trials

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about Novavax Quadrivalent vaccine

What is the Novavax Quadrivalent vaccine?

The Novavax Quadrivalent vaccine is an investigational vaccine developed by Novavax, Inc. for the prevention of seasonal influenza. It is a virus-like particle vaccine designed to target four influenza virus strains, and it has been studied in a Phase 2 clinical trial in healthy young adults.

What is the Novavax Quadrivalent vaccine used for?

The Novavax Quadrivalent vaccine is being developed for the prevention of influenza, a seasonal infectious disease. It is intended to protect against four influenza virus strains in a single formulation. The vaccine has been evaluated in a Phase 2 study in healthy adults aged 18 years and older.

Who makes the Novavax Quadrivalent vaccine?

The Novavax Quadrivalent vaccine is developed by Novavax, Inc., a biopharmaceutical company that trades on the Nasdaq under the ticker symbol NVAX. Novavax focuses on vaccine development, and this quadrivalent influenza candidate is part of its infectious disease pipeline.

What phase is the Novavax Quadrivalent vaccine in?

The Novavax Quadrivalent vaccine is in Phase 2 development. Its only recorded clinical trial, NCT01561768, was a completed Phase 2 study. The vaccine is investigational and has not been approved by the FDA for any indication.

What clinical trials is the Novavax Quadrivalent vaccine in?

The Novavax Quadrivalent vaccine has been studied in one clinical trial, NCT01561768, titled "A Study to Evaluate the Immune Response and Safety of a Seasonal Virus-Like Particle Influenza Vaccine in Healthy Young Adults." This completed Phase 2 trial enrolled 500 participants in Australia and was randomized, double-blind, and controlled.

What was the design of the Novavax Quadrivalent vaccine Phase 2 trial?

The Phase 2 trial of the Novavax Quadrivalent vaccine, NCT01561768, was a randomized, double-blind, controlled study that enrolled 500 healthy volunteers aged 18 years and older in Australia. It evaluated the immune response and safety of the seasonal virus-like particle influenza vaccine in healthy young adults.