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Safety Surveillance Study of ACAM2000® Vaccinia Vaccine

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ClinicalTrials.gov Identifier: NCT00927719
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Emergent BioSolutions

Brief 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.

Condition or disease Intervention/treatment
Smallpox Biological: ACAM2000® smallpox vaccine

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
Actual Enrollment : 897227 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Phase IV Enhanced Safety Surveillance Study of ACAM2000® in Military Personnel
Study Start Date : December 2008
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smallpox

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 Name: ACAM2000®




Primary Outcome Measures :
  1. To provide information concerning the safety following vaccination with ACAM2000® vaccinia vaccine [ Time Frame: Entire study duration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants that had received ACAM2000®, vaccinia virus Smallpox vaccine.
Criteria

Inclusion Criteria :

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

Exclusion Criteria :


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00927719


Locations
United States, California
Twentynine Palms, California, United States, 92278
United States, Kentucky
Fort Campbell North, Kentucky, United States, 42223
United States, Texas
Fort Bliss, Texas, United States, 79906
Fort Hood, Texas, United States, 76544
Sponsors and Collaborators
Emergent BioSolutions
Investigators
Study Director: Medical Director Emergent BioSolutions

Responsible Party: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT00927719     History of Changes
Other Study ID Numbers: H-406-005
First Posted: June 25, 2009    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018

Keywords provided by Emergent BioSolutions:
Smallpox
Smallpox Vaccine
Vaccinia virus
Military

Additional relevant MeSH terms:
Smallpox
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs