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Safety Surveillance Study of ACAM2000® Vaccinia Vaccine

NCT00927719 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 897227

Last updated 2024-03-18

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

ACAM2000® smallpox vaccine

Previous vaccination, no vaccine is administered in this study.

Sponsors & Collaborators

  • Emergent BioSolutions

    lead INDUSTRY

Principal Investigators

  • Medical Director · Emergent BioSolutions

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00927719 on ClinicalTrials.gov