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Safety Study of an Oral Vaccine to Prevent Seasonal Influenza

NCT01688297 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2017-05-12

No results posted yet for this study

Summary

The purpose of this study was to demonstrate the safety and immunogenicity of an oral vaccine tablet to prevent seasonal influenza. The study was a placebo controlled, double blinded trial at a single site. The study was conducted under two separate protocols. Initially single administrations at two dose levels (low dose and mid dose) of the oral vaccine was tested in a placebo controlled study (37 subjects). And subsequently a single high dose of the oral vaccine was tested in a separate placebo-controlled study (24 subjects).

Conditions

Interventions

BIOLOGICAL

VXA-A1.1 Oral Vaccine

One or two doses of replication incompetent adenovirus oral tablet vaccine

BIOLOGICAL

VXA Placebo Tablet

Off-white tablets similarly formulated to the active drug product tablets.

Sponsors & Collaborators

  • Vaxart

    lead INDUSTRY

Principal Investigators

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

  • Apinya Vutikullird, DO · WCCT

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-05-31
Completion
2015-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01688297 on ClinicalTrials.gov