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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01540929
First received: February 23, 2012
Last updated: August 2, 2012
Last verified: August 2012
History of Changes
  Purpose

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.

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: Prospective
Official Title: A Phase IV Post-licensure DOD Screening Accuracy Study in Military Personnel

Resource links provided by NLM:

MedlinePlus related topics: Smallpox
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 5000
Study Start Date: December 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study Group
Participants who had completed the DoD Smallpox Screening Form 600 (2 part format)

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants who had completed the DoD Smallpox Screening Form 600 (2 part format)

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540929

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Sanofi
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: August 2, 2012
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 June 18, 2013