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Novavax Quadrivalent vaccine

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment500
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01561768A Study to Evaluate the Immune Response and Safety of a Seasonal Virus-Like Particle Influenza Vaccine in Healthy Young AdultsPHASE2 COMPLETED 500Mar 1, 2012Jan 1, 2013Jul 18, 20134 Australia
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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 — 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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