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

NCT ID: NCT01540929

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5001 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-09-30

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.

Conditions

Smallpox

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Study Group

DoD Smallpox Screening Form 600 (2 part format)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emergent BioSolutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Emergent BioSolutions

Locations

Alexandria, Virginia, United States

Countries

United States

Other Identifiers

U1111-1122-1978

Identifier Type: OTHER

Identifier Source: secondary_id

H-406-002

Identifier Type: -

Identifier Source: org_study_id