Clinical Trials Logo
  1. Home
  2. Smallpox
  3. NCT01540929
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT05976100 - Study of the Safety, Tolerability, Pharmacokinetics of NIOCH-14 in Volunteers Aged 18-50 Years Phase 1
Completed NCT00258947 - Evaluation of Take and Safety of a Smallpox Vaccine in Healthy Young Adults Phase 2
Completed NCT00189969 - Take Rate, Immunogenicity and Safety of Elstree-BN Smallpox Vaccine in Healthy Vaccinia-Naive Subjects Phase 1
Terminated NCT00053508 - Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination Phase 2
Completed NCT01317238 - Safety and Efficacy of CJ Smallpox Vaccine in Previously Vaccinated Healthy Volunteers Phase 3
Completed NCT01056770 - Safety and Efficacy of CJ Smallpox Vaccine in Healthy Volunteers Phase 3
Terminated NCT00282581 - Safety Study of MVA Smallpox Vaccine in HIV-positive Subjects Who Are Vaccinia Naive Phase 1
Completed NCT00998543 - A Long-Term Study of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain) Phase 2
Withdrawn NCT00389103 - Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD) Phase 1
Completed NCT00133575 - ACAM 3000 MVA at Harvard Medical School Phase 1/Phase 2
Active, not recruiting NCT00103584 - Safety and Immunogenicity Study of LC16m8, a Modified Smallpox Vaccine, in Healthy, Previously Unvaccinated Volunteers Phase 1/Phase 2
Completed NCT00050505 - Expanded Dryvax Dilution Study in Previously Vaccinated Adults Phase 2
Completed NCT05846243 - Study on Immunogenicity, Reactogenicity and Safety of the VACΔ6 Vaccine in Volunteers Aged 18-60 Years Phase 2/Phase 3
Completed NCT05935917 - Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults Phase 1
Completed NCT00082446 - Combination Study With MVA BN and Dryvax Phase 1
Completed NCT00038987 - Vaccinia Virus Vaccine (APSV) in Vaccinia- Naive Subjects: PILOT Phase 1/Phase 2
Completed NCT05762523 - Safety and Tolerability Study of the VAC∆6 Vaccine in Volunteers Aged 18-40 Years Phase 1
Completed NCT04971109 - Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Day Phase 3
Completed NCT00646152 - Poly-ICLC to Prevent Respiratory Viral Infections A Safety Study Phase 1
Completed NCT01668537 - A Phase II Trial to Compare a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy Subjects Phase 2