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NCT00927719 · ClinicalTrials.gov registry record

Safety Surveillance Study of ACAM2000® Vaccinia Vaccine

A clinical trial of Smallpox, sponsored by Emergent BioSolutions.

Completed
Registry status
897,227
Enrollment target
4
Study locations

NCT00927719: Completed study of Smallpox, sponsored by Emergent BioSolutions.

NCT00927719 is a study of Smallpox that has completed, run by Emergent BioSolutions. The registered enrollment target is 897,227 participants, above the 2,876-participant average among 7 other Smallpox trials with a reported enrollment target (31097% higher). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00927719, a study of Smallpox, has completed, sponsored by Emergent BioSolutions.

COMPLETED
Registry status
897,227 participants
Enrollment target
4
Study locations

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 Studied

Interventions

  • BIOLOGICAL ACAM2000® smallpox vaccine

Study Locations (4)

Texas

  • - Fort Bliss
  • - Fort Hood

California

  • - Twentynine Palms

Kentucky

  • - Fort Campbell North

Trial Details

FieldValue
Enrollment Target 897,227 participants
Start Date 2008-12
Est. Completion 2017-12-31
Emergent BioSolutions

34 total trials

What the finished NCT00927719 record still lists

NCT00927719 is an observational study that tracks outcomes without assigning an intervention. Its 897,227 participants enrollment target places it among the larger protocols in the corpus, above the 2,876-participant average among 7 other Smallpox trials with a reported enrollment target (31097% higher).

The record links to 1 condition, with Smallpox appearing as the primary indexed condition, and to 1 intervention - of which ACAM2000® smallpox vaccine is the first listed.

NCT00927719 reports a single indexed study location in Texas, California, Kentucky.

Frequently Asked Questions

What is clinical trial NCT00927719 about?

NCT00927719 is a clinical study titled "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: ...

What is the current status of trial NCT00927719?

This trial is currently completed. The enrollment target is 897,227 participants. The study started on 2008-12. Estimated completion is 2017-12-31.

What conditions does trial NCT00927719 study?

This clinical trial studies the following conditions: Smallpox.

What interventions are being tested in trial NCT00927719?

The interventions under investigation include: ACAM2000® smallpox vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00927719?

This trial is sponsored by Emergent BioSolutions, which has 34 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00927719 being conducted?

This trial has 4 study locations across California, Kentucky, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00927719, the US trial registry maintained by the National Library of Medicine. NCT00927719 (large enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.