NCT00928577

Safety Surveillance Cohort Study of Vaccinia Vaccine (ACAM2000®)

A Phase IV Prospective Safety Surveillance Cohort Study Of ACAM2000® In Deploying Military Personnel

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 14,108 (actual)
• Sponsor: Emergent BioSolutions · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Accepted

Summary

Primary Objectives: * To compare the rates of myopericarditis (subclinical, suspected, probable, or confirmed) in deploying military subjects who received ACAM2000® vaccine to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts. * To identify cases of subclinical myopericarditis in deploying military subjects who received ACAM2000 vaccine. Secondary Objectives: * To compare the rates of severe and serious dermatologic adverse events observed in deploying military subjects who received ACAM2000® vaccine to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts. * To compare the rates of severe and serious neurological adverse events observed in deploying military subjects who received ACAM2000® vaccine to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts. * To compare the rates of adverse events observed in subjects approximately 10 days following their ACAM2000® vaccination to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts. * To evaluate potential risk factors associated with the development of confirmed, probable, and/or suspected ACAM2000-associated myopericarditis.

Detailed description

This is a prospective safety surveillance study in a US military Department of Defense (DoD) population. Military subjects either naive to smallpox immunization and have received ACAM2000® vaccine or who have previously been immunized with a vaccinia vaccine, usually Dryvax®, will be enrolled into the study. No vaccine will be administered as part of this study.

Conditions

• Smallpox

Timeline

• Start date: 2008-12-01
• Primary completion: 2014-12-01
• Completion: 2015-12-01
• First posted: 2009-06-26
• Last updated: 2024-04-04

Locations

4 sites across 1 country: United States