NCT00927719

Safety Surveillance Study of ACAM2000® Vaccinia Vaccine

A Phase IV Enhanced Safety Surveillance Study of ACAM2000® in Military Personnel

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 897,227 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Smallpox

Interventions

Type	Name	Description
BIOLOGICAL	ACAM2000® smallpox vaccine	Previous vaccination, no vaccine is administered in this study.

Timeline

• Start date: 2008-12-01
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2009-06-25
• Last updated: 2024-03-18

Locations

4 sites across 1 country: United States