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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01540929
First received: February 23, 2012
Last updated: May 25, 2016
Last verified: May 2016
  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:

Primary Outcome Measures:
  • The percent of SF600 forms that did not clearly support the subsequent decision to vaccinate. [ Time Frame: 1 year post-screening ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
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

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 
Study First Received: February 23, 2012
Last Updated: May 25, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Smallpox
ACAM2000®
Smallpox vaccine

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

ClinicalTrials.gov processed this record on August 25, 2016