Safety Surveillance Study of ACAM2000® Vaccinia Vaccine
|ClinicalTrials.gov Identifier: NCT00927719|
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : January 30, 2018
This is an enhanced safety surveillance study that will occur within the military Service Member population.
- To evaluate the rates of suspected, probable, and confirmed myocarditis and/or pericarditis in temporal association with ACAM2000® vaccination.
- 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.
|Condition or disease||Intervention/treatment|
|Smallpox||Biological: ACAM2000® smallpox vaccine|
|Study Type :||Observational|
|Actual Enrollment :||897227 participants|
|Official Title:||A Phase IV Enhanced Safety Surveillance Study of ACAM2000® in Military Personnel|
|Study Start Date :||December 2008|
|Primary Completion Date :||December 31, 2017|
|Study Completion Date :||December 31, 2017|
ACAM2000® vaccinia vaccine Cohort
Participants had received ACAM2000®, vaccinia virus Smallpox vaccine.
Biological: ACAM2000® smallpox vaccine
Previous vaccination, no vaccine is administered in this study.
Other Name: ACAM2000®
- To provide information concerning the safety following vaccination with ACAM2000® vaccinia vaccine [ Time Frame: Entire study duration ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00927719
|United States, California|
|Twentynine Palms, California, United States, 92278|
|United States, Kentucky|
|Fort Campbell North, Kentucky, United States, 42223|
|United States, Texas|
|Fort Bliss, Texas, United States, 79906|
|Fort Hood, Texas, United States, 76544|
|Study Director:||Medical Director||Emergent BioSolutions|