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NCT00927719 Clinical Trial

Safety Surveillance Study of ACAM2000® Vaccinia Vaccine

Smallpox Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00927719
Other study ID # H-406-005
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2008
Est. completion date December 31, 2017

Study information
Verified date March 2024
Source Emergent BioSolutions
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 897227
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years and older
Eligibility Inclusion Criteria : - Male and female military personnel >= 17 years of age. - Have received the ACAM2000® smallpox vaccine. Exclusion Criteria : - Not applicable.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• ACAM2000® smallpox vaccine
Previous vaccination, no vaccine is administered in this study.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Emergent BioSolutions

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To provide information concerning the safety following vaccination with ACAM2000® vaccinia vaccine Entire study duration
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