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NCT01540929 · ClinicalTrials.gov registry record
Post-licensure Department of Defense (DOD) Screening Accuracy Study in Military Personnel
A clinical trial of Smallpox, sponsored by Emergent BioSolutions.
- Completed
- Registry status
- 5,001
- Enrollment target
- 1
- Study location
NCT01540929: Completed study of Smallpox, sponsored by Emergent BioSolutions.
NCT01540929 is a study of Smallpox that has completed, run by Emergent BioSolutions. The registered enrollment target is 5,001 participants, below the 130,337-participant average among 7 other Smallpox trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01540929, a study of Smallpox, has completed, sponsored by Emergent BioSolutions.
- COMPLETED
- Registry status
- 5,001 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a retrospective study of the Department of Defense (DoD) Smallpox Screening Form 600s (SF600s) generated during screening of service members for possible immunization with the ACAM2000® smallpox vaccine. Primary Objective: * To evaluate the accuracy of the DoD smallpox vaccination screening process in military personnel. Secondary Objective: * To describe the number of subjects who are excluded from vaccination, stratified by the pre-defined categories for exclusion (separately for the Screened and Evaluable Populations).
Primary Outcome
ACAM2000® Screening Accuracy Review Committee (SARC) consensus that SF600 form did not support the decision to vaccinate divided by all subjects in the Evaluable Population.
Conditions Studied
Study Locations (1)
Virginia
- - Alexandria
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,001 participants |
| Start Date | 2009-09 |
| Est. Completion | 2012-09 |
What the finished NCT01540929 record still lists
NCT01540929 is an observational study that tracks outcomes without assigning an intervention. Its 5,001 participants enrollment target places it among the larger protocols in the corpus, below the 130,337-participant average among 7 other Smallpox trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Smallpox appearing as the primary indexed condition, and to 0 interventions.
NCT01540929 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT01540929 about?
NCT01540929 is a clinical study titled "Post-licensure Department of Defense (DOD) Screening Accuracy Study in Military Personnel". This is a retrospective study of the Department of Defense (DoD) Smallpox Screening Form 600s (SF600s) generated during screening of service members for possible immunization with the ACAM2000® smallpox vaccine. Primary Objective: * To evaluate the accuracy of the DoD smallpox vaccination screenin...
What is the current status of trial NCT01540929?
This trial is currently completed. The enrollment target is 5,001 participants. The study started on 2009-09. Estimated completion is 2012-09.
What conditions does trial NCT01540929 study?
This clinical trial studies the following conditions: Smallpox.
Who is sponsoring clinical trial NCT01540929?
This trial is sponsored by Emergent BioSolutions, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01540929 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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