Post-licensure Department of Defense (DOD) Screening Accuracy Study in Military Personnel
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 17 - Any |
| Updated: | 2/1/2018 |
| Start Date: | September 2009 |
| End Date: | September 2012 |
A Phase IV Post-licensure DOD Screening Accuracy Study in Military Personnel
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).
(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).
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.
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.
Inclusion Criteria:
- Military personnel ≥17 years of age.
- Completion of the DoD Smallpox Screening Form 600 (2-part format).
Exclusion Criteria:
We found this trial at
1
site
Click here to add this to my saved trials
