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NCT04634513 · ClinicalTrials.gov registry record · Phase 1
Shigella CVD 31000: Study of Responses With Shigella-ETEC Vaccine Strain CVD 1208S-122
A Phase 1 study of Shigella Infection and Enterotoxigenic Escherichia Coli Infection, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
- 1
- Study location
NCT04634513: Completed Phase 1 study of Shigella Infection and Enterotoxigenic Escherichia Coli Infection, sponsored by University of Maryland, Baltimore.
NCT04634513 is a Phase 1 study of Shigella Infection and Enterotoxigenic Escherichia Coli Infection that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 53 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04634513, a Phase 1 study of Shigella Infection and Enterotoxigenic Escherichia Coli Infection, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine whether a live, oral, combined Shigella-ETEC vaccine candidate, known as strain CVD 1208S-122, is safe and immunogenic.
Primary Outcome
Participants experiencing fever, diarrhea, or dysentery; solicited local adverse events; solicited systemic adverse events; and clinical safety laboratory adverse events
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL strain CVD 1208S-122
Study Locations (1)
Maryland
- University of Maryland, Baltimore, University of Maryland School of Medicine, Center for Vaccine Development and Global Health - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2022-09-29 |
| Est. Completion | 2024-10-01 |
| Phase | Phase 1 |
What the finished NCT04634513 record still lists
NCT04634513 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% lower).
The record links to 2 conditions, with Shigella Infection appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04634513 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04634513 about?
NCT04634513 is a clinical study titled "Shigella CVD 31000: Study of Responses With Shigella-ETEC Vaccine Strain CVD 1208S-122". The purpose of this study is to determine whether a live, oral, combined Shigella-ETEC vaccine candidate, known as strain CVD 1208S-122, is safe and immunogenic.
What is the current status of trial NCT04634513?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2022-09-29. Estimated completion is 2024-10-01.
What conditions does trial NCT04634513 study?
This clinical trial studies the following conditions: Shigella Infection, Enterotoxigenic Escherichia Coli Infection.
What interventions are being tested in trial NCT04634513?
The interventions under investigation include: Placebo (OTHER), strain CVD 1208S-122 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04634513?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04634513 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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Where NCT04634513's enrollment target sits among peer trials
53 948th of 2000 higher than 1,045 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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