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 Volunteers

NCT01688297 Phase 1 COMPLETED

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).

Details

Lead sponsor	Vaxart
Phase	Phase 1
Status	COMPLETED
Enrolment	61
Start date	2012-09
Completion	2015-04

Conditions

• Influenza

Interventions

• VXA-A1.1 Oral Vaccine
• VXA Placebo Tablet

Primary outcomes

• Safety of an oral vaccine tablet as measured by reported solicited (reactogenicity) and unsolicited adverse events — One year following last vaccination

Countries

United States