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NCT02388009 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of a Bioconjugate Vaccine Against Shigella Flexneri 2a
A Phase 1 study of Shigellosis, sponsored by LimmaTech Biologics.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT02388009 is a Phase 1 study of Shigellosis that has completed, run by LimmaTech Biologics. The registered enrollment target is 30 participants, below the 80-participant average among 3 other Shigellosis trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02388009, a Phase 1 study of Shigellosis, has completed, sponsored by LimmaTech Biologics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase I, single-blind, randomized, placebo-controlled, single-center study in healthy subjects using a staggered approach to dosing. 30 subjects will be randomized to receive 10 μg Flexyn2a candidate vaccine with or without adjuvant or placebo.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Flexyn2a
- BIOLOGICAL Flexyn2a plus adjuvant
Study Locations (1)
Maryland
- WRAIR Clinical Trial Center (CTC) - Silver Spring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-02 |
| Est. Completion | 2015-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02388009
The ClinicalTrials.gov registry entry for NCT02388009 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 80-participant average among 3 other Shigellosis trials with a reported enrollment target (62% lower). The listed sponsor is LimmaTech Biologics, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Shigellosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02388009 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02388009 about?
NCT02388009 is a clinical study titled "Safety and Tolerability of a Bioconjugate Vaccine Against Shigella Flexneri 2a". This is a phase I, single-blind, randomized, placebo-controlled, single-center study in healthy subjects using a staggered approach to dosing. 30 subjects will be randomized to receive 10 μg Flexyn2a candidate vaccine with or without adjuvant or placebo.
What is the current status of trial NCT02388009?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2015-02. Estimated completion is 2015-09.
What conditions does trial NCT02388009 study?
This clinical trial studies the following conditions: Shigellosis.
What interventions are being tested in trial NCT02388009?
The interventions under investigation include: Placebo (BIOLOGICAL), Flexyn2a (BIOLOGICAL), Flexyn2a plus adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT02388009?
This trial is sponsored by LimmaTech Biologics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02388009 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.