An observational study in Smallpox, sponsored by Emergent BioSolutions. Completed at 1 site in United States. Open to participants aged 17 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Emergent BioSolutions · Observational
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:
Secondary Objective:
Please note that we elected to post this study on the registry (clinicaltrials.gov) in the interests of transparency and because the study represented a post-licensure commitment to FDA for ACAM2000® smallpox vaccine. However, this study was not a clinical trial and did not involve the administration of any vaccine product nor the collection of any product performance or adverse event data. Rather, the purpose of the study was to determine the success rate for proper completion and use of Department of Defense (DoD) Screening Form 600s (SF600s). The SF600 is a form required to be completed prior to smallpox vaccination of DoD staff and is used to guide decision-making by DoD vaccination staff regarding offering, postponing, or denying vaccination. The study evaluated both the extent to which the SF600s were completed correctly and the extent to which they were correctly used to guide vaccination decision-making.
73 studies on the registry are indexed under Smallpox; 5 are open to participants now.
Browse Smallpox studies →Emergent BioSolutions is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
This study involves a review of DoD Smallpox Screening Form 600 (2 part format) that had been redacted of all personal information by the DoD. No individuals were involved in this study."
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
DoD Smallpox Screening Form 600 (2 part format)
The percent of SF600 forms that did not clearly support the subsequent decision to vaccinate.
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.
Time frame: 1 year post-screening
The record gives a start of Sep 2009, a primary completion of Sep 2012 and a completion of Sep 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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