An observational study in Smallpox, sponsored by Emergent BioSolutions. Completed at 4 sites in United States. Open to participants aged 17 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-04.
Sponsored by Emergent BioSolutions · Observational
Primary Objectives:
Secondary Objectives:
This is a prospective safety surveillance study in a US military Department of Defense (DoD) population. Military subjects either naive to smallpox immunization and have received ACAM2000® vaccine or who have previously been immunized with a vaccinia vaccine, usually Dryvax®, will be enrolled into the study.
No vaccine will be administered as part of this study.
74 studies on the registry are indexed under Smallpox; 5 are open to participants now.
Browse Smallpox studies →Emergent BioSolutions is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants in Cohort 1 are vaccinia vaccine naive and had received ACAM2000® vaccine as part of their Service Member readiness.
Participants in Cohort 2 did not receive ACAM2000® vaccine as part of their Service Member readiness process because they are still protected by previous vaccinia vaccination or are ineligible for current ACAM2000 vaccination either because of recency of prior vaccinia vaccination or for reasons solely attributable to conditions or characteristics of their contacts (such as a healthy soldier who is married to someone with a contraindicated condition).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria :
Participants are vaccinia vaccine-naive and have received ACAM2000 Smallpox vaccine as part of their Service Member readiness process.
Participants did not receive ACAM2000 Smallpox vaccine as part of their Service Member readiness process because they are still protected by previous vaccinia vaccination or are ineligible for current ACAM2000 vaccination either because of recency of prior vaccinia vaccination or for reasons solely attributable to conditions or characteristics of their contacts (such as a healthy soldier who is married to someone with a contraindicated condition).
The percentage and rate per 1,000 of participants with subclinical, suspected, probable, or confirmed myopericarditis following vaccination with either ACAM2000® Smallpox vaccine or other vaccinia vaccine.
Time frame: Day 10 post-vaccination
Number of participants reporting dermatologic adverse events of rash following vaccination with either ACAM2000 or other vaccinia vaccine
Dermatologic adverse events of rash are those that meet the following criteria: * Serious rashes persisting more than 48 hours that are distant from the vaccination site and * associated with systemic symptoms, or * involving mucous membranes.
Time frame: Day 10 post-vaccination
The record gives a start of Dec 2008, a primary completion of Dec 2014 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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