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

March 15, 2024 updated by: Emergent BioSolutions

A Phase IV Post-licensure 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).

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

5001

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Alexandria, Virginia, United States, 22301

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

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."

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Study Group
DoD Smallpox Screening Form 600 (2 part format)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year post-screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emergent BioSolutions

Investigators

  • Study Director: Medical Director, Emergent BioSolutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

February 23, 2012

First Submitted That Met QC Criteria

February 23, 2012

First Posted (Estimated)

February 29, 2012

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-406-002
  • U1111-1122-1978 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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