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NCT00928577 · ClinicalTrials.gov registry record
Safety Surveillance Cohort Study of Vaccinia Vaccine (ACAM2000®)
A clinical trial of Smallpox, sponsored by Emergent BioSolutions.
- Completed
- Registry status
- 14,108
- Enrollment target
- 4
- Study locations
NCT00928577: Completed study of Smallpox, sponsored by Emergent BioSolutions.
NCT00928577 is a study of Smallpox that has completed, run by Emergent BioSolutions. The registered enrollment target is 14,108 participants, below the 129,036-participant average among 7 other Smallpox trials with a reported enrollment target (89% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00928577, a study of Smallpox, has completed, sponsored by Emergent BioSolutions.
- COMPLETED
- Registry status
- 14,108 participants
- Enrollment target
- 4
- Study locations
Study Summary
Primary Objectives: * To compare the rates of myopericarditis (subclinical, suspected, probable, or confirmed) in deploying military subjects who received ACAM2000® vaccine to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts. * To identify cases of subclinical myopericarditis in deploying military subjects who received ACAM2000 vaccine. Secondary Objectives: * To compare the rates of severe and serious dermatologic adverse events observed in deploying military subjects who received ACAM2000® vaccine to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts. * To compare the rates of severe and serious neurological adverse events observed in deploying military subjects who received ACAM2000® vaccine to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts. * To compare the rates of adverse events observed in subjects approximately 10 days following their ACAM2000® vaccination to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts. * To evaluate potential risk factors associated with the development of confirmed, probable, and/or suspected ACAM2000-associated myopericarditis.
Conditions Studied
Study Locations (4)
Texas
- - Fort Bliss
- - Fort Hood
California
- - Twentynine Palms
Kentucky
- - Fort Campbell North
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14,108 participants |
| Start Date | 2008-12 |
| Est. Completion | 2015-12 |
What the finished NCT00928577 record still lists
NCT00928577 is an observational study that tracks outcomes without assigning an intervention. Its 14,108 participants enrollment target places it among the larger protocols in the corpus, below the 129,036-participant average among 7 other Smallpox trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Smallpox appearing as the primary indexed condition, and to 0 interventions.
NCT00928577 reports a single indexed study location in Texas, California, Kentucky.
Frequently Asked Questions
What is clinical trial NCT00928577 about?
NCT00928577 is a clinical study titled "Safety Surveillance Cohort Study of Vaccinia Vaccine (ACAM2000®)". Primary Objectives: * To compare the rates of myopericarditis (subclinical, suspected, probable, or confirmed) in deploying military subjects who received ACAM2000® vaccine to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive A...
What is the current status of trial NCT00928577?
This trial is currently completed. The enrollment target is 14,108 participants. The study started on 2008-12. Estimated completion is 2015-12.
What conditions does trial NCT00928577 study?
This clinical trial studies the following conditions: Smallpox.
Who is sponsoring clinical trial NCT00928577?
This trial is sponsored by Emergent BioSolutions, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00928577 being conducted?
This trial has 4 study locations across California, Kentucky, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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