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RSV F Vaccine with adjuvant

Phase 1

Respiratory Synctial Virus | Monoclonal antibody | Infectious Disease |Novavax, Inc.|Last Updated: Apr 28, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

RSV F Vaccine with adjuvant · 1 trial · 1 indication

Phase 1 1
NCT02296463A Phase I Randomized, Observer-Blinded, Dose-Ranging Study in Healthy Subjects 24 to <72 Months of AgeRespiratory Synctial Virus
COMPLETED32 Analytics
PHASE1COMPLETED
A Phase I Randomized, Observer-Blinded, Dose-Ranging Study in Healthy Subjects 24 to <72 Months of Age
Respiratory Synctial Virus
NCT0229646332
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Study Endpoints

Primary Endpoints

Numbers and percentages of subjects with solicited local and systemic AEs.
Up to Day 392

Solicited local and systemic AEs over the 7 days post injection; and all AES, solicited and unsolicited, including adverse changes in clinical laboratory parameters, over 56 days post- first injection. In addition, MAEs, SAEs, and SNMCs will be collected for one year.

Immunogenicity as assessed by serum IgG antibody levels specific for the F protein antigen as detected by enzyme-linked immunosorbent assay (ELISA) providing a standardized ELISA Unit (EU) reasout based on a standard reference sample.
Up to Day 392

Derived/ calculated endpoints based on these data will include: Geometric mean EU (GMEU) Geometric mean ratio (GMR) Seroresponse rate (SRR)

Secondary Endpoints

Epitope-specific immune responses to the RSV F protein antigen measured by serum titers in a competition ELISA assay using known-efficacious prophylactic antibody preparation, or in vitro neutralization assays using at least one prototype RSV/A and RSV/B
Up to Day 392
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Treatment Group AEXPERIMENTALDay 0: RSV F Vaccine with adjuvant, Day 28: RSV F Vaccine with adjuvant
Treatment Group BEXPERIMENTALDay 0: RSV F Vaccine with adjuvant, Day 28: Hepatitis A Vaccine
Treatment Group CEXPERIMENTALDay 0: RSV F Vaccine, Day 28: RSV F Vaccine
Treatment Group DEXPERIMENTALDay 0: RSV F Vaccine, Day 28: Hepatitis A Vaccine
Treatment Group EPLACEBO_COMPARATORDay 0: Placebo, Day 28: Hepatitis A Vaccine

Interventions

NameTypeDescription
RSV F Vaccine with adjuvant (0.5mL injection)BIOLOGICAL -
RSV F Vaccine (0.5mL injection)BIOLOGICAL -
Hepatitis A Vaccine (0.5mL injection)BIOLOGICAL -
Placebo (0.5mL injection)BIOLOGICAL -
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Eligibility Criteria

Age Range24 Months to 72 Months
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: 1. Healthy males and females, ≥24 months of age and \<72 months of age, without known chronic cardiopulmonary disease including especially persistent or frequently recurrent wheezing. 2. Free of other illnesses that are believed to increase the risks associated with influenza or...

Countries:Canada
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Frequently asked questions about RSV F Vaccine with adjuvant

What is RSV F Vaccine with Aluminum Adjuvant used for?

RSV F Vaccine with Aluminum Adjuvant is an investigational vaccine being studied for the prevention of Respiratory Syncytial Virus (RSV) infections. It is being evaluated in clinical trials for use in pregnant women to protect infants via maternal immunization, as well as in older adults and young children.

Who makes RSV F Vaccine with Aluminum Adjuvant?

RSV F Vaccine with Aluminum Adjuvant is being developed by Novavax, Inc., a biotechnology company traded on the NASDAQ under the ticker symbol NVAX. The vaccine is currently in clinical development and has not yet been approved by regulatory authorities.

What phase is RSV F Vaccine with Aluminum Adjuvant in?

RSV F Vaccine with Aluminum Adjuvant has completed clinical trials in Phase 1, Phase 2, and Phase 3. The most advanced completed study was a Phase 3 trial evaluating maternal immunization to protect infants from RSV. The vaccine remains investigational and is not yet approved.

What clinical trials has RSV F Vaccine with Aluminum Adjuvant been in?

RSV F Vaccine with Aluminum Adjuvant has been studied in four completed clinical trials. These include NCT02247726, a Phase 2 maternal immunization study in pregnant women; NCT02296463, a Phase 1 dose-ranging study in toddlers; NCT02624947, a Phase 3 maternal immunization efficacy trial; and NCT03026348, a Phase 2 study in older adults.

Is RSV F Vaccine with Aluminum Adjuvant the same as other RSV vaccines?

RSV F Vaccine with Aluminum Adjuvant is a specific vaccine formulation developed by Novavax that includes the RSV F protein combined with an aluminum adjuvant. It is distinct from other RSV vaccine candidates that may use different antigens or adjuvant systems, such as Matrix-M1.