Safety Surveillance Study of ACAM2000® Vaccinia Vaccine

Emergent BioSolutions

Status: Completed

Conditions: Smallpox

Treatments: Biological: ACAM2000® smallpox vaccine

Study type: Observational

Funder types: Industry

Identifiers

NCT00927719

H-406-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 897,227 patients

Sex: All

Ages: 17+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

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

Exclusion Criteria :

• Not applicable.

Trial design

897,227 participants in 1 patient group

ACAM2000® vaccinia vaccine Cohort

Description:

Participants had received ACAM2000®, vaccinia virus Smallpox vaccine.

Treatment:

Biological: ACAM2000® smallpox vaccine