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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01540929
First Posted: February 29, 2012
Last Update Posted: May 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
  Purpose

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).

Condition
Smallpox

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Phase IV Post-licensure DOD Screening Accuracy Study in Military Personnel

Resource links provided by NLM:


Further study details as provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Primary Outcome Measures:
  • 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.


Enrollment: 5001
Study Start Date: December 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study Group
DoD Smallpox Screening Form 600 (2 part format)

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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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."
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540929


Locations
United States, Virginia
Alexandria, Virginia, United States, 22301
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01540929     History of Changes
Other Study ID Numbers: H-406-002
U1111-1122-1978 ( Other Identifier: WHO )
First Submitted: February 23, 2012
First Posted: February 29, 2012
Last Update Posted: May 26, 2016
Last Verified: May 2016

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Smallpox
ACAM2000®
Smallpox vaccine

Additional relevant MeSH terms:
Smallpox
Poxviridae Infections
DNA Virus Infections
Virus Diseases