Safety Surveillance Study of ACAM2000® Vaccinia Vaccine

March 14, 2024 updated by: Emergent BioSolutions

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

897227

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Twentynine Palms, California, United States, 92278
    • Kentucky
      • Fort Campbell North, Kentucky, United States, 42223
    • Texas
      • Fort Bliss, Texas, United States, 79906
      • Fort Hood, Texas, United States, 76544

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants that had received ACAM2000®, vaccinia virus Smallpox vaccine.

Description

Inclusion Criteria :

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

Exclusion Criteria :

  • Not applicable.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ACAM2000® vaccinia vaccine Cohort
Participants had received ACAM2000®, vaccinia virus Smallpox vaccine.
Biological: ACAM2000® smallpox vaccine
Previous vaccination, no vaccine is administered in this study.
Other Names:
  • ACAM2000®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To provide information concerning the safety following vaccination with ACAM2000® vaccinia vaccine
Time Frame: Entire study duration
Entire study duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emergent BioSolutions

Investigators

  • Study Director: Medical Director, Emergent BioSolutions

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

June 24, 2009

First Submitted That Met QC Criteria

June 24, 2009

First Posted (Estimated)

June 25, 2009

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-406-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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