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VXA-A1.1 H1 Vaccine

Phase 1

Seasonal Influenza Preventative Vaccine Pharmacodynamics | Vaccines | Infectious Disease |Vaxart, Inc|Trials Updated: May 30, 2018

VXA-A1.1 H1 Vaccine target and mechanism

ModalityVaccines

Also known as VXA-A1.1 H1 Tablet Vaccine (small)

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

VXA-A1.1 H1 Vaccine clinical trials

VXA-A1.1 H1 Vaccine · 1 trial · 1 indication

Phase 1 1
NCT03121339Pharmacodynamic Open-Label Trial With VXA-A1.1 Oral H1 Vaccine in Healthy AdultsSeasonal Influenza Preventative Vaccine Pharmacodynamics
COMPLETED8 Analytics
PHASE1COMPLETED
Pharmacodynamic Open-Label Trial With VXA-A1.1 Oral H1 Vaccine in Healthy Adults
Seasonal Influenza Preventative Vaccine Pharmacodynamics
NCT031213398
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Study Endpoints

Primary Endpoints

PD: Location of disintegration
7 days

Site of initial and complete disintegration of the study DP

PD: Time to disintegration
7 days

Time of initial and complete disintegration of the study DP

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
Treatment A - Fasting ConditionACTIVE_COMPARATORRadio-labeled VXA-A1.1 H1 Tablet Vaccine (small) and VXA-A1.1 H1 Tablet Vaccine (large) will be administered to fasted subjects.
Treatment B - Fed ConditionACTIVE_COMPARATORRadio-labeled VXA-A1.1 H1 Tablet Vaccine (small) and VXA-A1.1 H1 Tablet Vaccine (large) will be administered to subjects with a small snack.

Interventions

NameTypeDescription
VXA-A1.1 H1 Tablet Vaccine (small)BIOLOGICALTableted oral H1 vaccine (\~140 mg tablet)
VXA-A1.1 H1 Tablet Vaccine (large)BIOLOGICALTableted oral H1 vaccine (\~275 mg tablet)
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Eligibility Criteria

Age Range18 Years to 49 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male volunteers aged 18 - 49 years, inclusive * Willing and able to give written informed consent/HIPAA authorization form * In good health (no clinically significant health concerns), as determined by medical history, physical examination, 12-lead ECG, vital signs and laborat...

Countries:United States
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