Clinical Trials Logo

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).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01540929
Study type Observational
Source Emergent BioSolutions
Contact
Status Completed
Phase
Start date September 2009
Completion date September 2012

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
Withdrawn NCT00389103 - Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD) Phase 1
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
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