NCT01540929

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,001

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 29, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

3 years

First QC Date

February 23, 2012

Last Update Submit

March 15, 2024

Conditions

Smallpox

Keywords

SmallpoxACAM2000®Smallpox vaccine

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Study Group

DoD Smallpox Screening Form 600 (2 part format)

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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."

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Alexandria, Virginia, 22301, United States

Location

MeSH Terms

Conditions

Smallpox

Condition Hierarchy (Ancestors)

Poxviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Medical Director

    Emergent BioSolutions

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2012

First Posted

February 29, 2012

Study Start

September 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

March 18, 2024

Record last verified: 2024-03

Locations

US(1)