Safety Surveillance Study of ACAM2000® Vaccinia Vaccine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00927719|
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : August 10, 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|
|Actual Primary Completion Date :||December 31, 2017|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|