Smallpox Clinical Trial
Official title:
A Phase IV Post-licensure DOD Screening Accuracy Study in Military Personnel
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).
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. ;
| 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 | |
| Withdrawn |
NCT00389103 -
Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD)
|
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 |