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NCT00928577 · ClinicalTrials.gov registry record

Safety Surveillance Cohort Study of Vaccinia Vaccine (ACAM2000®)

A clinical trial of Smallpox, sponsored by Emergent BioSolutions.

Completed
Registry status
14,108
Enrollment target
4
Study locations

NCT00928577 is a study of Smallpox that has completed, run by Emergent BioSolutions. The registered enrollment target is 14,108 participants, below the 129,036-participant average among 7 other Smallpox trials with a reported enrollment target (89% lower). The trial reports 4 study locations across 3 states.

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The verdict

NCT00928577, a study of Smallpox, has completed, sponsored by Emergent BioSolutions.

COMPLETED
Registry status
14,108 participants
Enrollment target
4
Study locations

Study Summary

Primary Objectives: * To compare the rates of myopericarditis (subclinical, suspected, probable, or confirmed) in deploying military subjects who received ACAM2000® vaccine to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts. * To identify cases of subclinical myopericarditis in deploying military subjects who received ACAM2000 vaccine. Secondary Objectives: * To compare the rates of severe and serious dermatologic adverse events observed in deploying military subjects who received ACAM2000® vaccine to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts. * To compare the rates of severe and serious neurological adverse events observed in deploying military subjects who received ACAM2000® vaccine to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts. * To compare the rates of adverse events observed in subjects approximately 10 days following their ACAM2000® vaccination to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive ACAM2000 vaccine due to recency of prior vaccination (as determined by DoD healthcare providers) or due to conditions or characteristics of their contacts. * To evaluate potential risk factors associated with the development of confirmed, probable, and/or suspected ACAM2000-associated myopericarditis.

Conditions Studied

Smallpox

Study Locations (4)

Texas

  • - Fort Bliss
  • - Fort Hood

California

  • - Twentynine Palms

Kentucky

  • - Fort Campbell North

Trial Details

FieldValue
Enrollment Target 14,108 participants
Start Date 2008-12
Est. Completion 2015-12

Sponsor

Emergent BioSolutions

34 total trials

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What the Registry Record Tells You About NCT00928577

The ClinicalTrials.gov registry entry for NCT00928577 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 14,108 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 129,036-participant average among 7 other Smallpox trials with a reported enrollment target (89% lower). The listed sponsor is Emergent BioSolutions, which has 34 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Smallpox appearing as the primary indexed condition, and to 0 interventions.

NCT00928577 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Texas, California, Kentucky.

Frequently Asked Questions

What is clinical trial NCT00928577 about?

NCT00928577 is a clinical study titled "Safety Surveillance Cohort Study of Vaccinia Vaccine (ACAM2000®)". Primary Objectives: * To compare the rates of myopericarditis (subclinical, suspected, probable, or confirmed) in deploying military subjects who received ACAM2000® vaccine to rates among subjects positioned to deploy who would be personally eligible to receive ACAM2000 vaccine but do not receive A...

What is the current status of trial NCT00928577?

This trial is currently completed. The enrollment target is 14,108 participants. The study started on 2008-12. Estimated completion is 2015-12.

What conditions does trial NCT00928577 study?

This clinical trial studies the following conditions: Smallpox.

Who is sponsoring clinical trial NCT00928577?

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

Where is trial NCT00928577 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.