Safety Surveillance Study of ACAM2000® Vaccinia Vaccine

Status Completed

Clinical Trial Summary

This is an enhanced safety surveillance study that will occur within the military Service Member population. 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.

Clinical Trial Description

The Armed Forces Health Surveillance Activity (AFHSA) will perform comprehensive health surveillance through the operation of the Defense Medical Surveillance System (DMSS). Demographic and medical information gathered within monthly reports from the DMSS will be collected from approximately 100,000 to 200,000 military Service Members who received the ACAM2000® smallpox vaccine. ;

Study Design

Related Conditions & MeSH terms

Smallpox

Clinical Trial Details

NCT number	NCT00927719
Study type	Observational
Source	Emergent BioSolutions
Contact
Status	Completed
Phase
Start date	December 2008
Completion date	December 31, 2017

View Details

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