Safety Surveillance Study of ACAM2000® Vaccinia Vaccine

Completed

• Conditions: Smallpox

• Registration Number: NCT00927719
• Lead Sponsor: Emergent BioSolutions

Brief 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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-06-24
• Study First Submitted QC: 2009-06-24
• Study First Posted: 2009-06-25
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 897227

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To provide information concerning the safety following vaccination with ACAM2000® vaccinia vaccine	Entire study duration