Post-licensure Department of Defense (DOD) Screening Accuracy Study in Military Personnel
This is a prospective study within the Department of Defense (DoD) military population involving the collection of DoD Smallpox Screening Form 600s (SF600s). SF600s will be collected from subjects that received or did not receive an 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).
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Phase IV Post-licensure DOD Screening Accuracy Study in Military Personnel|
- The percent of subjects that were incorrectly vaccinated [ Time Frame: 1 year post screening ] [ Designated as safety issue: No ]ACAM2000® Screening Accuracy Review Committee (SARC) consensus was that subject should not have been vaccinated divided by all subjects in the Evaluable Population.
|Study Start Date:||December 2008|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Participants who had completed the DoD Smallpox Screening Form 600 (2 part format)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540929
|United States, Virginia|
|Alexandria, Virginia, United States, 22301|
|Study Director:||Medical Director||Sanofi Pasteur Inc.|