Recent Updates
Recently added Catalysts

RSV F Vaccine with Aluminum Adjuvant

Phase 2

Respiratory Syncytial Viruses | Monoclonal antibody | Respiratory |Novavax, Inc.|Last Updated: Dec 6, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03026348Safety and Immunogenicity Study to Evaluate Single- or Two-Dose Regimens Of RSV F Vaccine With and Without Aluminum Phosphate or Matrix-M1™ Adjuvants In Clinically-Stable Older AdultsPHASE2 COMPLETED 300 — — Jan 1, 2017May 18, 2018Dec 6, 20215 Australia
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Neutralizing antibody titers to at least one RSV/A strain
Day 0, 21, 28
Subjects with solicited local and systemic AEs occurring within the 7-day period following dosings on Day 0 and Day 21 and all adverse events, solicited and unsolicited, occurring within the 56-day period of Day 0.
Day 0 - Day 6, Day 21 - Day 27; Day 0 - Day 56
Secondary Endpoints
Serum concentrations of antibodies competitive with palivizumab (i.e., PCA) for binding to the RSV F protein.
Day 0, 21, 28, 56, 119, 385
Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen.
Day 0, 21, 28, 56, 119, 385
Counts of IFN-γ spot forming units following in vitro stimulation of Day 0, Day 7, and Day 28 PBMC isolates with RSV F peptides.
Day 0, 7, 28
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Treatment Group AACTIVE_COMPARATORDay 0 RSV F Vaccine 135µg/0.5mL Day 21 Phosphate Buffer
Treatment Group BACTIVE_COMPARATORDay 0 Treatment / Formulation 1 Day 21 Phosphate Buffer
Treatment Group CACTIVE_COMPARATORDay 0 Treatment / Formulation 1 Day 21 Treatment / Formulation 1
Treatment Group DACTIVE_COMPARATORDay 0 Treatment / Formulation 2 Day 21 Phosphate Buffer
Treatment Group EACTIVE_COMPARATORDay 0 Treatment / Formulation 2 Day 21 Treatment / Formulation 2
Treatment Group FACTIVE_COMPARATORDay 0 Treatment / Formulation 3 Day 21 Phosphate Buffer
Treatment Group GACTIVE_COMPARATORDay 0 Treatment / Formulation 3 Day 21 Treatment / Formulation 3
Treatment Group HACTIVE_COMPARATORDay 0 Treatment / Formulation 4 Day 21 Phosphate Buffer
Treatment Group JACTIVE_COMPARATORDay 0 Treatment / Formulation 4 Day 21 Treatment / Formulation 4
Treatment Group KACTIVE_COMPARATORDay 0 Treatment / Formulation 5 Day 21 Phosphate Buffer
Treatment Group LACTIVE_COMPARATORDay 0 Treatment / Formulation 5 Day 21 Treatment / Formulation 5
Treatment Group MPLACEBO_COMPARATORDay 0 Phosphate Buffer Day 21 Phosphate Buffer
Interventions
NameTypeDescription
RSV F Vaccine with Aluminum Phosphate AdjuvantBIOLOGICAL -
RSV F VaccineBIOLOGICAL -
Matrix-M1 AdjuvantBIOLOGICAL -
Phosphate BufferOTHER -
Unlock Study Design Details
Eligibility Criteria
Age Range60 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites5

Inclusion Criteria: 1. Males and females 60 through 80 years of age who are ambulatory and live in the community or in an assisted-living facility that provides minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living. Subjects may have one or ...

Countries:Australia
Unlock Eligibility Criteria