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VXA-BYW.10 Vaccine

Phase 1

Seasonal Influenza B | Vaccines | Infectious Disease |Vaxart, Inc|Trials Updated: May 31, 2018

VXA-BYW.10 Vaccine target and mechanism

ModalityVaccines

Also known as VXA-BYW.10 (Low Dose) Oral Vaccine

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

VXA-BYW.10 Vaccine clinical trials

VXA-BYW.10 Vaccine · 1 trial · 1 indication

Phase 1 1
NCT02547792Assessment of an Oral Influenza B Vaccine Tablet (VXA-BYW.10) Following Single Dose Administration in Healthy AdultsSeasonal Influenza B
COMPLETED54 Analytics
PHASE1COMPLETED
Assessment of an Oral Influenza B Vaccine Tablet (VXA-BYW.10) Following Single Dose Administration in Healthy Adults
Seasonal Influenza B
NCT0254779254
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Study Endpoints

Primary Endpoints

Safety and Tolerability of Single High Dose of an Oral Influenza B Tablet Vaccine
Day 28

Safety determined by reported solicited (reactogenicity) and unsolicited AEs.

Secondary Endpoints

Immunogenicity of Single high Dose of an Oral Influenza B Tablet Vaccine
Day 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
VXA-BYW.10 (Low Dose) Oral VaccineEXPERIMENTALSingle administration of Influenza B (Low Dose) oral vaccine tablets
VXA-BYW.10 (High Dose) Oral VaccineEXPERIMENTALSingle administration of Influenza B (High Dose) oral vaccine tablets
Placebo TabletsPLACEBO_COMPARATORMatching placebo dose (size and number of tablets) to low dose vaccine (part 1) and high dose (part 2)

Interventions

NameTypeDescription
VXA-BYW.10 (Low Dose) Oral VaccineBIOLOGICALEnteric coated tablet for oral delivery
VXA-BYW.10 (High Dose) Oral VaccineBIOLOGICALEnteric coated tablet for oral delivery
Placebo TabletsOTHEREnteric coated tablet for oral delivery
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Eligibility Criteria

Age Range18 Years to 49 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * In good health as established by medical history, physical examination, and laboratory testing at the time of enrollment. Exclusion Criteria: * Positive for B influenza by HAI. * Has had an influenza vaccine in the past 2 years. * Current history of chronic alcohol use and/o...

Countries:New Zealand
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