Post-licensure Department of Defense (DOD) Screening Accuracy Study in Military Personnel
This study has been completed.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
First received: February 23, 2012
Last updated: May 25, 2016
Last verified: May 2016
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).
||Observational Model: Cohort
Time Perspective: Retrospective
||A Phase IV Post-licensure DOD Screening Accuracy Study in Military Personnel
Primary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2012 (Final data collection date for primary outcome measure)
DoD Smallpox Screening Form 600 (2 part format)
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.
|Ages Eligible for Study:
||17 Years and older (Child, Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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."
- Military personnel ≥17 years of age.
- Completion of the DoD Smallpox Screening Form 600 (2-part format).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540929
|Alexandria, Virginia, United States, 22301 |
Sanofi Pasteur, a Sanofi Company
||Sanofi Pasteur Inc.
||Sanofi Pasteur, a Sanofi Company
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 23, 2012
||May 25, 2016
||United States: Food and Drug Administration
Keywords provided by Sanofi:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 29, 2016
DNA Virus Infections