Is a
Clinical Study attributes
NCT Number
Health Conditions in Trial
Trial Recruitment Size
610
Trial Sponsor
Clinical Trial Start Date
2012
0Primary Completion Date
2014
0Study Completion Date
2015
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Prevention0
Intervention Type
Biological0
Intervention Name
VXA Placebo Tablet0
VXA-A1.1 Oral Vaccine0
Interventional Trial Phase
Phase 10
Participating Facility
Official Name
Randomized Phase 1 Double-Blinded Placebo Controlled Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Seasonal Influenza A Vaccine and dsRNA Adjuvant Administered Orally to Healthy Volunteers0
Last Updated
May 12, 2017
0Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Quadruple0
Masked Party
Care Provider0
Outcomes Assessor0
Participant0
Investigator0
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).
Timeline
No Timeline data yet.
Further Resources
No Further Resources data yet.
