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NCT01761123 · ClinicalTrials.gov registry record · Phase 1
Immunogenicity of Seasonal Influenza by Delivery Directly to Ileum
A Phase 1 study of Seasonal Influenza, sponsored by Vaxart.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT01761123: Completed Phase 1 study of Seasonal Influenza, sponsored by Vaxart.
NCT01761123 is a Phase 1 study of Seasonal Influenza that has completed, run by Vaxart. The registered enrollment target is 37 participants, below the 438-participant average among 3 other Seasonal Influenza trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01761123, a Phase 1 study of Seasonal Influenza, has completed, sponsored by Vaxart.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
the purpose of the study is to determine the safety and tolerability of VXA-A1.1, an adjuvanted adenoviral based influenza vaccine, when delivery is targeted to the ileum, using a radio controlled capsule. The secondary objective is to evaluate the immune response (cellular and humoral) of two doses of VXA-A1.1 oral vaccine.
Primary Outcome
Frequency and magnitude of adverse events
Conditions Studied
Interventions
- BIOLOGICAL VXA-A1.1
Study Locations (1)
Kentucky
- Scintipharma - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
What the finished NCT01761123 record still lists
NCT01761123 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 438-participant average among 3 other Seasonal Influenza trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Seasonal Influenza appearing as the primary indexed condition, and to 1 intervention - of which VXA-A1.1 is the first listed.
NCT01761123 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT01761123 about?
NCT01761123 is a clinical study titled "Immunogenicity of Seasonal Influenza by Delivery Directly to Ileum". the purpose of the study is to determine the safety and tolerability of VXA-A1.1, an adjuvanted adenoviral based influenza vaccine, when delivery is targeted to the ileum, using a radio controlled capsule. The secondary objective is to evaluate the immune response (cellular and humoral) of two doses...
What is the current status of trial NCT01761123?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2013-01. Estimated completion is 2014-10.
What conditions does trial NCT01761123 study?
This clinical trial studies the following conditions: Seasonal Influenza.
What interventions are being tested in trial NCT01761123?
The interventions under investigation include: VXA-A1.1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01761123?
This trial is sponsored by Vaxart, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01761123 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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