Safety Surveillance Study of ACAM2000® Vaccinia Vaccine

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.

Completed

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Key information

Conditions

Smallpox DNA Virus Infections Infections Poxviridae Infections Vaccinia Virus Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Twentynine Palms, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male and female military personnel >= 17 years of age.
Have received the ACAM2000® smallpox vaccine.

Exclusion criteria

Not applicable.

Treatment and study plan

ACAM2000® smallpox vaccine

Biological

Previous vaccination, no vaccine is administered in this study.

Other names: ACAM2000®

Primary outcomes

To provide information concerning the safety following vaccination with ACAM2000® vaccinia vaccine

Time frame: Entire study duration

Sponsors and collaborators

Lead sponsor

Emergent BioSolutions

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2017
Study completion: 2017
First posted: Jun 25, 2009
Registry last updated: Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed