Post-licensure Department of Defense (DOD) Screening Accuracy Study in Military Personnel

Completed

• Conditions: Smallpox

• Registration Number: NCT01540929
• Lead Sponsor: Emergent BioSolutions

Brief 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).

Detailed Description

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-02-23
• Study First Posted: 2012-02-29
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5001

Inclusion Criteria

• Military personnel ≥17 years of age.
• Completion of the DoD Smallpox Screening Form 600 (2-part format).

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percent of SF600 forms that did not clearly support the subsequent decision to vaccinate.	1 year post-screening	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.