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NCT01688297 · ClinicalTrials.gov registry record · Phase 1
Safety Study of an Oral Vaccine to Prevent Seasonal Influenza
A Phase 1 study, sponsored by Vaxart.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT01688297 is a Phase 1 study that has completed, run by Vaxart. The registered enrollment target is 61 participants.
The verdict
NCT01688297, a Phase 1 study, has completed, sponsored by Vaxart.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
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).
Interventions
- BIOLOGICAL VXA-A1.1 Oral Vaccine
- BIOLOGICAL VXA Placebo Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2012-09 |
| Est. Completion | 2015-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01688297
The ClinicalTrials.gov registry entry for NCT01688297 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vaxart, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which VXA-A1.1 Oral Vaccine is the first listed.
NCT01688297 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01688297 about?
NCT01688297 is a clinical study titled "Safety Study of an Oral Vaccine to Prevent Seasonal Influenza". 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...
What is the current status of trial NCT01688297?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2012-09. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01688297?
The interventions under investigation include: VXA-A1.1 Oral Vaccine (BIOLOGICAL), VXA Placebo Tablet (BIOLOGICAL).
Who is sponsoring clinical trial NCT01688297?
This trial is sponsored by Vaxart, which has 19 total clinical trials registered on ClinicalTrials.gov.
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