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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01540929

Enrollment

5001

Registered

2012-02-29

Start date

2009-09-30

Completion date

2012-09-30

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smallpox

Keywords

Smallpox, ACAM2000®, Smallpox vaccine

Brief 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).

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

17 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

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

Countries

United States

Outcome results