CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 179 enrolled
Drug / intervention
VXA-A1.1 +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02918006
NCT02918006Phase 2Completed
CompareCT.gov

Phase 2 Randomized, Controlled, Human Influenza A (H1N1) Challenge Study Following Administration of an Oral H1N1 HA Adenoviral-Vector Based Seasonal Influenza Vaccine and dsRNA Adjuvant to Healthy Adult Volunteers

Vaxart·interventional·Posted Sep 28, 2016·Updated Oct 6, 2022

In Brief

A Phase 2 clinical trial evaluating VXA-A1.1, Fluzone®, and 2 other interventions for Influenza. Completed, enrolled 179 participants across 1 site.

Detailed Summary

A Phase 2 Randomized, Placebo- and Active-Controlled, Human Influenza A/California/04/2009 (H1N1) Challenge Study Following Administration of an Oral H1N1 Hemagglutinin (HA) Adenoviral-Vector Based Seasonal Influenza Vaccine and dsRNA Adjuvant (VXA-A1.1) to Healthy Adult Volunteers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
CollaboratorsBiomedical Advanced Research and Development Authority

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 28, 2016
Enrollment StartAug 31, 2016
Primary CompletionAug 8, 2017
Study CompletionJan 19, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.8 years ago

Interventions

VXA-A1.1biological

Enteric coated oral vaccine tablet

Fluzone®biological

Fluzone Quadravalent (Fluzone®) influenza vaccine (QIV) suspension for intramuscular (IM) injection

Placebo Tabletsother

Placebo tablets similar in size, color and number to the active oral tablet vaccine drug product

Saline Solution for Placebo IM Injectionother