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Assessment of an Oral Influenza B Vaccine Tablet (VXA-BYW.10) Following Single Dose Administration in Healthy Adults

NCT02547792 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2018-05-31

No results posted yet for this study

Summary

This is a phase 1, single-center, placeb-controlled, double-blind study. The purpose of this study is to determine the safety and immunogenicity of an oral vaccine tablet to prevent seasonal influenza B tested at two dose levels (low and high dose). The study will enroll 27 subjects in the low dose cohorts (3 sentinel open label subjects followed by 24 subjects (randomized 2:1 to vaccine vs placebo, respectively). Subsequently, 27 subjects will be enrolled in the high dose cohort in a similar manner as to the low dose cohort. Safety and immunogenicity will be evaluated at Day 28. Long term safety follow-up will be evaluated through 1 year post vaccination.

Conditions

  • Seasonal Influenza B

Interventions

BIOLOGICAL

VXA-BYW.10 (Low Dose) Oral Vaccine

Enteric coated tablet for oral delivery

BIOLOGICAL

VXA-BYW.10 (High Dose) Oral Vaccine

Enteric coated tablet for oral delivery

OTHER

Placebo Tablets

Enteric coated tablet for oral delivery

Sponsors & Collaborators

  • Vaxart

    lead INDUSTRY

Principal Investigators

  • David Liebowitz, MD, PhD · Vaxart, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-20
Primary Completion
2016-11-21
Completion
2016-11-21

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02547792 on ClinicalTrials.gov