Safety Surveillance Study of ACAM2000® Vaccinia Vaccine
NCT ID: NCT00927719
Last Updated: 2024-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
897227 participants
OBSERVATIONAL
2008-12-31
2017-12-31
Brief Summary
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Primary Objective:
* To evaluate the rates of suspected, probable, and confirmed myocarditis and/or pericarditis in temporal association with ACAM2000® vaccination.
Secondary Objectives:
* To evaluate the rates of cardiovascular adverse events in temporal association with ACAM2000® vaccination.
* To evaluate the rates of neurological adverse events in temporal association with ACAM2000® vaccination.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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ACAM2000® vaccinia vaccine Cohort
Participants had received ACAM2000®, vaccinia virus Smallpox vaccine.
ACAM2000® smallpox vaccine
Previous vaccination, no vaccine is administered in this study.
Interventions
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ACAM2000® smallpox vaccine
Previous vaccination, no vaccine is administered in this study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have received the ACAM2000® smallpox vaccine.
Exclusion Criteria
17 Years
ALL
Yes
Sponsors
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Emergent BioSolutions
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Emergent BioSolutions
Locations
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Twentynine Palms, California, United States
Fort Campbell North, Kentucky, United States
Fort Bliss, Texas, United States
Fort Hood, Texas, United States
Countries
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References
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Decker MD, Garman PM, Hughes H, Yacovone MA, Collins LC, Fegley CD, Lin G, DiPietro G, Gordon DM. Enhanced safety surveillance study of ACAM2000 smallpox vaccine among US military service members. Vaccine. 2021 Sep 15;39(39):5541-5547. doi: 10.1016/j.vaccine.2021.08.041. Epub 2021 Aug 26.
Other Identifiers
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H-406-005
Identifier Type: -
Identifier Source: org_study_id
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