Post-licensure Department of Defense (DOD) Screening Accuracy Study in Military Personnel
|ClinicalTrials.gov Identifier: NCT01540929|
Recruitment Status : Completed
First Posted : February 29, 2012
Last Update Posted : January 30, 2018
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.
- To evaluate the accuracy of the DoD smallpox vaccination screening process in military personnel.
- 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).
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||5001 participants|
|Official Title:||A Phase IV Post-licensure DOD Screening Accuracy Study in Military Personnel|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
DoD Smallpox Screening Form 600 (2 part format)
- The percent of SF600 forms that did not clearly support the subsequent decision to vaccinate. [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540929
|United States, Virginia|
|Alexandria, Virginia, United States, 22301|
|Study Director:||Medical Director||Emergent BioSolutions|