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NCT01540929 Clinical Trial

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

Smallpox Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01540929
Other study ID # H-406-002
Secondary ID U1111-1122-1978
Status Completed
Phase
First received
Last updated
Start date September 2009
Est. completion date September 2012

Study information
Verified date March 2024
Source Emergent BioSolutions
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 5001
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years and older
Eligibility Inclusion Criteria: - Military personnel =17 years of age. - Completion of the DoD Smallpox Screening Form 600 (2-part format). Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Emergent BioSolutions

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The percent of SF600 forms that did not clearly support the subsequent decision to vaccinate. 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
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