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Completed

NCT Number: NCT01540929

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

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).

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Key information

Conditions

Smallpox DNA Virus Infections Infections Poxviridae Infections Virus Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alexandria, Virginia, 22301, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Emergent BioSolutions

Industry

Registry information

Official study title

A Phase IV Post-licensure DOD Screening Accuracy Study in Military Personnel

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Feb 29, 2012
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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