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NCT01336699 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of Two Live, Attenuated Oral Shigella Sonnei Vaccines: WRSs2 and WRSs3
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 89
- Enrollment target
NCT01336699 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 89 participants.
The verdict
NCT01336699, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 89 participants
- Enrollment target
Study Summary
Phase 1, randomized, double-blind, placebo controlled, dose-escalation, inpatient study of single doses of S. sonnei. Health adult subjects, ranging in age from 18 to 45 years of age (inclusive) will be screened. Enroll serial groups up to 90 subjects. The primary objective is to evaluate safety and tolerance of WRSs2 by monitoring presence, frequency and severity of clinical signs and symptoms. A secondary objective is to evaluate the immune response in blood and stool following ingestion of WRSs2 and WRSs3.
Interventions
- OTHER Placebo
- BIOLOGICAL WRSs2
- BIOLOGICAL WRSs3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2013-01-07 |
| Est. Completion | 2015-05-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01336699
The ClinicalTrials.gov registry entry for NCT01336699 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01336699 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01336699 about?
NCT01336699 is a clinical study titled "Safety and Immunogenicity of Two Live, Attenuated Oral Shigella Sonnei Vaccines: WRSs2 and WRSs3". Phase 1, randomized, double-blind, placebo controlled, dose-escalation, inpatient study of single doses of S. sonnei. Health adult subjects, ranging in age from 18 to 45 years of age (inclusive) will be screened. Enroll serial groups up to 90 subjects. The primary objective is to evaluate safety and...
What is the current status of trial NCT01336699?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 89 participants. The study started on 2013-01-07. Estimated completion is 2015-05-12.
What interventions are being tested in trial NCT01336699?
The interventions under investigation include: Placebo (OTHER), WRSs2 (BIOLOGICAL), WRSs3 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01336699?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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