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: April 25, 2014
Last verified: April 2014
  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:


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.


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
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
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:
No publications provided

Responsible Party: Sanofi ( 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: April 25, 2014
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 September 18, 2014